Catherine B., Ph.D.

Senior Regulatory Affairs Consultant

AREAS OF EXPERTISE:

Catherine provides consulting services and cost-effective training worldwide. Catherine started her career in research in the US and later moved back to Europe, to work as a regulatory affairs manager in two different CROs based in the UK. There, she gained extensive experience in European registration for a wide variety of products. Since then, Catherine has been consulting on FDA and European regulatory affairs. Recently, she has broader her experience with Japanese’s submission. In addition, she has extended her expertise to Regulatory Compliance and Quality Assurance.

EXPERIENCE SUMMARY:

Vaccines

• Gap Analysis for several vaccines from a US CTD submission to move forward with a EU CTD submission (Modules 2 and 3)
• Conversion of the old EU format and old Canadian format to a CTD format with incorporation of variations or post-marketing changes
• Preparation of a Type II variation in order to add a new manufacturing site to a licensed product in Europe
• Preparation of a Type II Variation and two expert reports (CMC Section) for a veterinarian vaccine
• Preparation of Modules 2, 3, 4 and 5 of a CTD for a recombinant Hepatitis B (DNA vaccine)
• Preparation of Module 3 of a CTD from NDA, Annual reports and supplements for a conjugate vaccine
• Preparation of Module 2 and Module 5 of a CTD for EU submission of a conjugate vaccine
• Preparation of CMC section (BLA application) from batch records and SOPs and of toxicological section for two conjugate vaccines (pneumococcal and meningococcal), submission through mutual recognition and centralised procedure in Europe and US and follow-up
• Preparation of 4 US DMFs for conjugate vaccine products and 10 EU DMFs in CTD format for antibiotics
• Monitor all undesirable effects during the clinical trial for both the HIV vaccine and the cancer vaccine.
• Preparation for pre-IND meeting (pre-IND package) and IND (including investigator brochure) for:

1. a HIV viral vector vaccine
2. an autologous cancer vaccine
3. a human gene therapy (with RAC Committee)
4. a biological product for UTI
5. a dermatologic cream

Small Molecules/New Chemical Entity

• Preparation of an IND for a small peptide for autoimmune disease and follow up.
• Prepare CTD for Olopatadine Ophthalmic Solution in the treatment of allergen-medicated.
• Develop strategy and write Modules 2, 3, 4 and 5 for fluoroquinone for dermatological indication.
• Provide advice to a regulatory strategy core team to follow the development of news NCE for ophthalmic products.

Dermatology

• Preparation of a parallel scientific advice meeting between the FDA and the EMEA and the Sponsor for a pediatric orphan product
• Preparation for a pre-IND meeting followed by an IND for an orphan product
• Preparation of the application for the Orphan Product Designation
• Preparation of an IMPD for nanotechnological product
• Preparation for a pre-IND meeting with pre-IND package and then the IND and follow up for a hydroquinone cream

Respiratory Disease

• Prepare IND and IMPD for a combination product (2 active ingredients and a medical device) to be used for the treatment of COPD. Prepare Scientific advice for Europe.

Orphan Products

• Prepare orphan application to request the orphan designation for several products (total submission 4)
• Prepare NIH Grant for orphan clinical trial
• Prepare pre-IND meeting/package and IND submission for 2 orphan products

Cell therapy product

• Prepare pre-IND meeting/package and electronic IND submission for 3 products

Combination product

• Prepare a regulatory assessment for a combination product (drug/medical device) for periodontitis

Regulatory Compliance/Quality Assurance

GMP Compliance

• Act as a Senior Director of Regulatory Compliance for a large generic company
• Assist, prepare and review a comparability protocol to transfer the manufacturing process between 2 manufacturing sites
• Review analytical validation method package for all critical methods (release drug substance and drug product) in preparation of a PAI with the FDA.
• Assessment of a QC Laboratory for a French Pharmaceutical Company in view of an FDA pre-approval inspection (write umbrella procedures, train the personnel, review the QC part of the quality systems) for an anti-allergy product.
• Audit of Quality Systems for two Pharmaceuticals under Consent Decree. Review batch records for release of those products under Consent Decree.
• Audit of supplier and third party manufacturer for GMP compliance (prepare questionnaire)
• Audit of several sub-manufacturing contractors for their adequacy of manufacturing clinical trial materials (i.e. BL3 facility, QC and QA organization, warehouse and shipping capabilities…etc).

GLP Compliance

• Audits of animal research laboratories (GLP oriented) for IND filing and preparation of manufacturing plant (GMP oriented) for FDA pre-approval inspection.

GCP Compliance

• Audit of one clinical trial site (GCP oriented) for a Phase 1 HIV Vaccine and inspection of the clinical documentation (source documents) for Phase 3 for a MAA.
• Audit of Clinical Quality System (Record Management, Pharmacovigilance, Monitoring) and assessment of responses provided to EU Health Authority for the clinical deficiencies.

Quality Assurance

• Set up Quality system for small biotech companies (HIV product and cancer vaccine).
• Preparation of SOPs, Batch Records and technology transfer to GMP manufacturer for a viral vaccine delivery system.
• Preparation of process validation master plan and assay transfer plan for a urinary tract infection drug.
• Assist small biotech companies in the requirement for method development, write technical reports, assay validation reports.

Training

For two governmental bodies and multiple medium sized pharmaceutical companies

• European Clinical Trial Requirements including GCP
• Making Challenging Decisions to Take Products from Discovery to Commercialization
• Building a Relationship with the FDA and Preparing for effective US Product Licensing
• Good Laboratory Practices Basics: Application to the Pharmaceutical Industries
• Good Manufacturing Practices: An Overview of Regulatory Requirements fro Drug, Biologics and Devices
  Target Product Profile (TPP) as a Tool for Managing FDA Communication and Product Development

EDUCATION

PhD Program – Option Cell Biology and Biochemistry

Supervisor: Dr M Webber
“Purification and characterisation of two cholinergic differentiation factors.”
Laboratoire de Pharmacologie et Toxicologie Fondamentales – Toulouse, France

LANGUAGES

• French – fluent
• English – fluent

Larry S.

Senior Compliance Consultant

AREAS OF EXPERTISE:

Larry has over 20 years of FDA experience encompassing virtually all of the FDA field positions. He also has eighteen years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the medical device industry. He has personally designed quality systems, prepared regulatory submissions (510(k), IDE and PMA) and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, he was the Industry Representative on the FDA Circulatory Systems panel. Finally, he is a seasoned educator/speaker with over 250 public presentations to audiences ranging from senior executives, physicians, technical personnel, other medical personnel, major media, and the general public.

EXPERIENCE SUMMARY:

The FDA Group, Worcester, MA

Services offered to FDA regulated businesses include planning, creating, and auditing quality systems to USA and international standards. Creation of clinical plans including protocol development, case report form development, implementing and managing clinical trials. Also, Design Control to meet FDA requirements and representing clients in FDA meetings. I am a professional public speaker who can train persons on all aspects of FDA requirements, and practical and successful solutions to FDA problems.

Audits of quality systems performed upon request to assess compliance multiple international regulatory systems. A matrix has been developed that covers FDA Quality System Regulation, 21 CFR Part 820, European Standards for Medical Device Sections, European Standard ISO 13485:2003 Medical Devices, Canadian rules Medical Devices Regulations SOR/98-282, and Japan’s MHLW Ministerial Ordinance No. 169 Medical Device Manufacturing. This is more complex than an FDA QSR audit and entails more time to create the written report, but firms will have a report addressing all 4 international requirements.

Recent Clients

Fisher Paykel Healthcare

Performed QSR FDA Mock Audits at two of the US facilities that import, service and distribute in the USA medical devices designed and made at the New Zealand manufacturing site. The audit finding were well received by the corporate VP of QA, who commented that he was impressed that the issues could be found in what he considered a high level QA program.

Arbor Pharmaceuticals

Performed a cGMP audit for Arbor at a contract manufacturer that is one of the largest generic drug manufacturers in the world. Covered OSS occurrences and investigations, laboratory procedures, CAPA process, process validation and controls, facility controls and maintenance, preventative maintenance of equipment, and employee training.

Terumo Cardiovascular Systems (3 month contract)

Served as an FDA consultant internally. Provided feedback to product teams regarding aspects of their projects that would fall under FDA scrutiny. Sat in on daily Plant Leadership Team meetings to provide an FDA perspective on the quality system issues. Prepared a detailed training program on Process Validation. Performed Mock FDA QSR audits at two manufacturing sites within the USA.

Care Innovations – An Intel-GE Company

Completed two QSR (21CFR Part 820 and ISO 13485) audits at device facilities in the UK and United States. The audits were performed for Care Innovations, a major U.S firm that was entering into a business arrangement with the UK (Tunstall) and US (AMAC) firms. Using a risk based approach I gave the client reports detailing needed improvement and received positive feedback from the client.

AngioDynamics, Inc.

This audit was a two week “Mock FDA” audit at a site in Georgia manufacturing sterile disposable devices and electronic devices. A final week was used to prepare a detailed audit report and complex remediation actions for the firm. That audit and report resulted in another scheduled audit for another facility in New York owned by the same corporation.

UNITED STATES FOOD & DRUG ADMINISTRATION, November 2000 – September 2011

• Supervisory Investigator, FDA Saint Louis Office, March 2009 – September, 2011
  Directed all of the FDA operations at the Saint Louis, MO office for FDA. This included work planning for investigators, training of investigators, reviewing inspection and investigation reports for technical and legal requirements. Received an FDA commendation for development of newly hired investigators. Trained on Incident Command Systems (ICS) to serve as a leader in multiagency response to national incidents.
• Acting Director of Compliance, FDA Los Angeles District, September 2008 – March 2009
  Directed the activities of 7 Compliance Officers. Monitored all on-going projects, and assured adequate resources to assure timely and accurate review of violative inspections, investigations, and sample collections. Negotiated with FDA Centers, Office of Chief Counsel, and Office of Enforcement regarding legal cases. Chaired meetings with regulated firms regarding requirements necessary to meet FDA legal requirements.
• Director, Import Operations Branch -FDA Los Angeles District, November 2003 to September 2008
  Responsible for managing the operations of over 100 FDA employees located at offices in San Pedro, Carson, Long Beach, Ontario, and Los Angeles International Airport. It was the responsibility of these employees to review all FDA regulated products offered for entry and sale into the United States from foreign sources through the Ports of Long Beach and Los Angeles, and Ontario and Los Angeles International Airports. Successfully reorganized the branch to optimize personnel efficiencies, regularly chaired Import Broker meetings to gain feedback on their perception of FDA Import Operations. Received a special award from FDA’s Office of Criminal Investigation for support the Import Branch provided for development of criminal cases. Acted as the FDA Los Angeles District Director, during the Director’s absence.
• Compliance Officer, FDA Los Angeles District, June 2002 – November 2003
  Perform technical reviews of inspection reports and sample analyses and determine the potential need for further regulatory action by FDA. Work assignments were almost exclusively complex medical device and pharmaceutical inspections and require both risk and legal assessments to formulate regulatory enforcement plans. In my first six months in this position, I authored six Warning Letters. The Warning Letters involved four pharmaceutical, and two medical device firms. Charges cited in the letters ranged from cGMP (QSR), to unapproved new drugs, failure to comply with an OTC Monograph, and failure to submit a 510(k) Premarket Notification. Also chaired meetings requested by companies to discuss their regulatory status. The meetings involved both Corporate and Private Counsel and senior executives for major device firms.
• Investigator (Medical Device Specialist), FDA Los Angeles District, November 2000 – June 2002
  Served as a technical specialist in the Los Angeles District for all aspects of Medical Device regulatory compliance. Performed inspections of manufacturers of high-risk medical device firms for both GMP/QSR compliance, as well as sponsor/monitor and clinical investigator inspections for IDE, IRB, and Informed Consent compliance. Certified in the QSIT Approach, and certified for knowledge of the Quality System Regulation. In a 15 month period had two warning letters issued for QSIT inspections, and one recall initiated as a result of a QSIT inspection. Served as a trainer for less experienced investigators for QSIT inspections, Bio-Research Monitoring inspections, food sampling, and recall initiation and monitoring. Selected in January 2002, as the New Hire Training Coordinator for the Los Angeles District Domestic Investigations Branch.

INDUSTRY EXPERIENCE

President/Founder, March 1997- November 2000
MEDICAL DEVICE DEVELOPMENT CORPORATION, Fullerton, CA

Founded this consulting firm to advise medical device manufacturers of management responsibility, organizational structures, processes, procedures, and requirements to take a medical device concept to the market. Clients were primarily start-up companies who engaged the services of the firm to provide strategic guidance in the areas of clinical studies, design development, quality systems development, product liability issues, and government approvals (both U.S. and international). Successfully developed strategic plans, and designed and implemented program planning. Services also included preparation of complex regulatory submissions (IDE, 510(k), PMA, Product Dossiers, Product Technical Files). When requested represented the client before FDA, Notified Bodies, Physicians, Investors, Corporate Partners, and Boards of Directors.

Vice President, Regulatory Affairs, Clinical Research, and Quality Assurance, 1995 -1997
CORDIS WEBSTER, INC. a Johnson & Johnson Company, Baldwin Park, CA 91706

Joined the senior staff of the company shortly after the acquisition of Webster Laboratories by Cordis Corporation. Cordis Webster was a mature company manufacturing and developing Class 2 and 3 products for the cardiac electrophysiology market. Successfully reorganized the Clinical and regulatory departments, and developed systems to assure that all clinical studies and regulatory submissions efficiently met development schedules. Developed a strategic plan that allowed the company to amend a PMA to assure that FDA would approve it. Oversaw quality systems development and management that led to a successful FDA PMA inspection and to ISO-9001 certification and CE Marking. Designed and implemented an innovative clinical protocol that was used to support a PMA product that was approved for a $100 million dollar market.

Vice President, Regulatory Affairs, Clinical Research, and Quality Assurance, 1994 – 1995
CARDIMA CORPORATION, Fremont, CA 94538

Key member of the senior staff of this early stage company developing products for the electrophysiology market. Utilizing team-building efforts, lead the company in a reassessment of priorities allowing for more focus and program accountability. Successfully negotiated with FDA over a complex IDE, to obtain an approval in 30 days. Set up all procedures and plans for a multi- center clinical study. Interacted with venture capital company representatives in efforts to secure additional financing. Lead the company’s ISO/GMP program, and development of management systems to assure efficient operations in an environment of total employee involvement.

Vice President, Regulatory Affairs/Quality Assurance, 1993 – 1994
CARDIAC PATHWAYS CORPORATION, Sunnyvale, CA 94086

As member of the senior management team of this start-up company, developed strategic programs in the development of an integrated system for diagnosis and treatment of cardiac arrhythmias. Directed the implementation of a clinical program to comply with U.S. FDA and European Union requirements. Responsible for overseeing R&D efforts to assure adequate documentation of design control. Prepared all regulatory submissions for both U.S. and international clinical evaluation and marketing approval of
various cardiovascular catheters and diagnostic systems. Personally wrote one 510(k) and two IDE’s.

Vice President, Regulatory Affairs, Clinical Research, and Quality Assurance, 1990 – 1993
BAXTER HEALTHCARE CORPORATION, Edwards LIS Division, Irvine, CA 92714

Senior management position responsible for directing all of the quality assurance programs, clinical evaluation programs, and preparation of government regulatory submissions required for marketing medical devices in the United States and throughout the world. Edwards LIS Division was a fully integrated manufacturer of medical devices for vascular surgery and interventional cardiology. Directed implementation of a preproduction quality assurance program significantly improving the product development cycle and product reliability. Effectively reorganized Quality, Regulatory, and Clinical departments to facilitate a company-wide Total Quality Assurance approach. Established an International RA function and established plans for obtaining the “CE” mark in Europe. Certified by
Baxter Healthcare Corporation as an examiner for the Baldrige (Baxter) Quality Award. Attended all FDA Circulatory Systems Advisory Panel meetings as the Industry Representative (four year appointment by FDA 1989-1993)

Vice President, Regulatory Affairs, Clinical Research and Quality Assurance 1986 – 1990
RETROPERFUSION SYSTEMS, INC., Costa Mesa, CA

Joined the start-up company team to develop an innovative electromechanical medical device to be utilized in interventional cardiology in the treatment of coronary artery disease. Interfaced with design engineers and physicians and oversaw pre-clinical research. Prepared the original Investigational Device Exemption (IDE) application that was approved by FDA in 30 days from the first submission. Set up the clinical evaluation program, implemented and managed an international multicenter clinical evaluation and prepared the Premarket Approval Application (PMA) which was accepted by FDA for filing in 45 days from the original submission. Obtained international approvals for export. Organized and staffed the Quality Assurance department, established pre-production QA functions and created procedures to meet Good Manufacturing Practices (GMP) regulations.

Manager, Regulatory Affairs, 1984 – 1986
UNITEK CORPORATION, Subsidiary of Bristol-Myers Company, Monrovia, CA

Responsible for all of the regulatory requirements for this large fully integrated manufacturer of mechanical, electronic and chemical medical devices and pharmaceuticals. Managed the company employee safety program, the environmental health program, product complaint department and internal GMP Audit program. Prepared all regulatory submissions (510(k), IDE, Product Registrations). Member of the strategic planning committee for the company and a key member of all product development teams.

Manager, Regulatory and Clinical Affairs 1982 – 1984
HEYER SCHULTE DIVISION, American Hospital Supply Corporation, Goleta, CA

Responsible for the regulatory and clinical programs for this medium sized manufacturer of implantable silicone devices utilized in neurology, cardiology, orthopedics, and plastic surgery. A member of the project teams that successfully developed and introduced to the market new class II and class III products. Managed the clinical evaluation of two class III devices and the preparation of all regulatory submissions (510(k), IDE, PMA). Performed internal GMP audits and was the liaison with corporate GMP and GLP auditors, and state and federal inspectors.

EARLY FDA EXPERIENCE, 1972-1982

U. S. Food and Drug Administration, Los Angeles, CA
Small Business Representative, July 1979- March 1982

Established the first West Coast office in the Small Business Assistance program, and served as a representative of the CDRH, Division of Small Manufacturers Assistance. Provided regulatory guidance to developers of new medical devices. Performed on-site visits at manufacturing locations and advised on procedures necessary to meet GMP and IDE requirements. Met with Institutional Review Board representatives to advise them of regulatory requirements. Served as an FDA spokesperson at numerous government and industry meetings, presenting regulatory requirements for medical device manufacturers.

U. S. Food and Drug Administration, Los Angeles, CA
Consumer Affairs Officer, September 1975- June 1979

Directed the consumer, industry, and press information programs for the Los Angeles District. Prepared and implemented professional education programs for teachers, health educators, nurses, and physicians. Primary public spokesperson in Los Angeles for all FDA related matters.

U. S. Food and Drug Administration, Los Angeles, CA
Consumer Safety Officer (Investigator) June 1972 – August 1975

Performed inspections and investigations of all product areas regulated by FDA. Specialties included sterilization and injury/illness investigations. Trained other investigators. Awarded the FDA Commendable Service Award in 1974 for outstanding performance as an investigator

EDUCATION

California State University, Fullerton, Bachelor of Arts, 1970. Biological Sciences

Golden Gate University, Santa Barbara, CA, MBA Program: One year Completed; 1982-83

AWARDS

FDA Commendable Service Award, 1974

FDA Special Achievement Award, FDA Office of Criminal Investigations, 2009

CERTIFICATIONS

Certified in Regulatory Affairs (RAC) by the Regulatory Affairs Professionals Society, 1991

APPOINTMENTS

Member, Board of Directors

National Alliance on Medical Illness, Southern Illinois Division, a non-profit organization offering assistance to persons or families dealing with mental illness, and advocating on their behalf.
August, 2011 to present

Industry Representative

FDA Circulatory Systems Advisory Panel, FDA Center for Devices and Radiological Health
Four-year term, ending June 1993.

Instructor

Design Control Seminars, Noblitt & Rueland,
1994 – 2000

PUBLICATIONS

“What to Expect When You Are Inspected “

Endovascular Today Magazine, January 2004

“Design Verification”

Medical Devices and Diagnostics Industry. Vol. 16, No. 1, January, 1994

“Practical Aspects of the Clinical Evaluation of a Medical Device”

Medical Devices and Diagnostics Industry. Vol. 7, No. 4, April, 1985

AFFILIATIONS

Member

Regulatory Affairs Professionals Society, 1982 – Present

President

Regulatory Affairs Professionals Society, Western Section, 1985 – 1986

Member

American Society for Quality, 1976 – Present

Richard N.

Senior Compliance Consultant

AREAS OF EXPERTISE:

Richard N. has more than 32 years of experience as a US Food & Drug Administration Investigator. He has assisted pharmaceutical manufacturers in gaining FDA approval to market pharmaceutical products in the United States, using his experience in inspecting pharmaceutical manufacturers worldwide and in managing a pharmaceutical testing laboratory.

EXPERIENCE SUMMARY:

The FDA Group, Worcester, MA

Development work for multiple clients in US, China, Vietnam, and Taiwan: FDA inspection preparation, GMP audits, training, SOP and validation protocol development, mock inspections. Product involvement includes APIs, solid oral dosage forms, sterile injectables, and biological products (monoclonal antibodies). Experience in ANDA development for tablet dosage forms, including process validation, cleaning validation, stability study design, bioequivalence protocols, GLP audits of clinical facilities.

US Food & Drug Administration Investigator (1973-2005)

• Supervised and reviewed the work of 8-15 pharmaceutical chemists.
• Reviewed and approved pharmaceutical analysis worksheets and GMP inspectional reports of staff on a daily basis.
• Trained and developed skills of laboratory staff in technical areas such as: ISO 17025 laboratory accreditation, creation and maintenance of quality systems, and GMP inspectional techniques.
• Coached and mentored staff as needed, addressing and resolving performance and conduct issues, and motivating and rewarding excellence.
• Inspected pharmaceutical manufacturing firms for compliance with FDA regulations worldwide on team inspections. Principal area of expertise is in laboratory operations: both quality control aspects and research and development of analytical methods. Findings on two inspections led to FDA’s issuance of Warning Letters and denial of firms to market in the USA.
• Member of Editorial Review Board and author of Data Presentation and Statistics chapter for the FDA Laboratory Manual, used throughout the FDA.
• Part of management team that recently gained ISO 17025 certification for the FDA Philadelphia Pharmaceutical Laboratory
• Chemist in a drug analytical laboratory, with expertise in gamma ray spectroscopy and the analysis of radiopharmaceutical products.
• Adverse analytical findings for Iron-59 injection led to FDA’s first recall of a radiopharmaceutical product
• Gained familiarity with a wide range of analytical equipment to include HPLC, Gas Chromatography, UV/Visible and IR Spectroscopy.
• Published research results on design of an HPLC gamma ray detector in Analytical Chemistry; presented research findings as papers at various professional society meetings.
• Inspected radiopharmaceutical manufacturers throughout theUS as a technical expert.

HIGHLIGHTS AND SUMMARY:

• 32 years of professional experience with the US Food and Drug Administration as a pharmaceutical chemist, laboratory manager, and inspector of FDA-regulated pharmaceutical API and dosage form manufacturers.
• Approximately 60 inspections of pharmaceutical manufacturers in Asia, Europe, and the United States while employed with FDA.
• In-depth, recent experience in successfully preparing an FDA pharmaceutical laboratory for ISO 17025 laboratory accreditation.
• Expertise in analytical method validation, analytical software/spreadsheet development and validation, writing laboratory SOPs and work instructions.
• 12 years FDA experience in review of DMFs and the CMC portion of NDAs, ANDAs and NADAs submitted by regulated industry.

OTHER RELEVANT EXPERIENCE:

• Volunteer for 15 years at Recording for the Blind and Dyslexic (RFB&D www.rfbd.org), a US nationwide organization that produces spoken textbooks and professional materials for blind and print-impaired people.
• Qualified as an RFB&D specialty reader in Chemistry, Physics, and Mathematics: have read and interpreted dozens of college level textbooks in these areas.
• Avid runner who has completed four marathons in recent years. I have found that the methodical training required for marathon races is an excellent way to develop persistence, patience and focus, as well as develop my athletic ability.

LANGUAGE SKILLS:

• German (conversational and technical review of printed documents)
• Chinese (Mandarin: limited conversational, some experience in technical review)
• French (limited conversational)

HONORS, AWARDS, PROFESSIONAL SOCIETIES:

• FDA Award of Merit, 2004: for contributions to the FDA Laboratory Manual
• FDA Award of Merit, 1989: for contributions toward development of a Laboratory Bioanalytical Techniques training course
• Rho Chi Pharmacy Honor Society (inducted 1979)
• Sigma Xi Science Honorary Society (inducted 1967)
• American Chemical Society (ACS) Member (25 years)
• American Association of Pharmaceutical Science (AAPS) Member (6 years)

EDUCATION AND OTHER EXPERIENCE:

• Oberlin College, Oberlin, Ohio: Bachelor of Arts in Chemistry, graduated with High Honors in Chemistry (1967)
• Yale University, New Haven, CT: Master of Science in Chemistry (1973)
• Northeastern University, Boston, MA: Master of Science in Radio­pharmaceutical Science, with highest grade point average of class in the Health Sciences Department (1979)
• Harvard University Extension, Cambridge, MA : Computer Science (1982-1985)
• United States Army, 1968-1970; Honorable Discharge with rank of Sergeant

George F.

Senior Compliance Consultant

AREAS OF EXPERTISE:

George F. has more than 30 years of experience as a US Food & Drug Administration Investigator. His FDA experience includes pharmaceutical manufacturing, repacking, and compliance. He has broad experience in drug, medical device, clinical investigators, food, dietary supplements, and cosmetic inspections. He specializes in Drug cGMP, NDA/ANDA/DMF, and clinical investigator inspections.

EXPERIENCE SUMMARY:

The FDA Group, Worcester, MA

• Comprehensive cGMP Inspections and QA Evaluations: includes on-site inspections of manufacturing facilities for compliance with cGMP regulations and/or Application commitments.
• Comprehensive Quality Assurance Program Evaluations: evaluation of Quality Systems controlling manufacturing and identification of compliance problems. Formal assistance in developing procedures, validation plans, corrective actions, etc. to meet cGMP requirements.
• NDA/ANDA Pre-Approval Inspections, Audits, and Readiness Assessments: includes assessments at every stage of development, including early development (Phase I, etc.) to time of NDA/ANDA/DMF filing to identify potential problems as companies head toward a Pre-Approval Inspection and Regulatory Submissions.
• cGMP and Pre-Approval Training: insight into FDA’s expectations regarding a number of issues including development, manufacture of clinical materials, Pre-Approval inspections, laboratory and manufacturing operation, scale-up, validation, and post-approval cGMPs.
• Vendor Assessments and cGMP Audits: assistance in identifying suitable vendors that are in compliance with cGMPs and avoiding the costly mistakes of using non-compliant sources.
• Liaison and Coordination Activities with FDA Field and Headquarters Offices: includes written correspondence or personal meetings.
  

US Food & Drug Administration Investigator (1976-2006)

Specialized in Drug cGMP, NDA/ANDA/DMF, and clinical investigator inspections. Conducted hundreds of Pre-Approval Inspections of major domestic and international pharmaceutical manufacturers of a variety of dosage forms and active pharmaceutical ingredients. Inspected approximately 200 foreign drug manufacturers and clinical investigators in Europe, Russia, Israel, China, Korea, Japan, Taiwan, Singapore, and Australia during 43 trips, each lasting from three to five weeks.

PRESENTATIONS:

• Wrote the pamphlet, “FDA Guide to Inspections of Dosage Form Drug Manufacturers – cGMPs”
• Speaker at Good Manufacturing Conference at the University of Georgia
• Speaker at the Southern Biotechnology Drug Development Conference
• Speaker at Vanderbilt University on Informed Consent for Research
• Presentation at Bioresearch Workshop at Vanderbilt University
• Presentation at Bioresearch Workshop at University of Alabama at Birmingham
• Speaker at Vanderbilt Research Forum
• Speaker at the Korean PDA 2006 meeting in Seoul, Korea

RECOGNITION AND AWARDS:

• Group Recognition Award for outstanding performance and teamwork, under hazardous conditions in conducting inspections in China for a firm that harvests Ma Huang grass and manufactures Ephedra Powder – 2004
• Twice selected for the Dupre’ S. Spiller Award as the Outstanding Employee of the Year in the Nashville District – 2000 and 2003
• Hammer Award from Former Vice President Al Gore for Bioresearch Implementation Workshop Team – 1999
• FDA’s Group Recognition Award for outstanding expertise, dedication, and cooperation while working to bring the operation of a major manufacturer into compliance with Current Good Manufacturing Practices – 1999
• Group Recognition Award for outstanding performance in the planning for and conduct of training for the Bioresearch Industry – 1997
• Ronald H. Brown Award, issued by the U. S. Department of Commerce, for technical assistance in Israel – 1996
• Nominated by the Nashville District for the Patrick J. Pouzar Investigator of the Year Award – 1992
• Award of Merit as a member of the of the Tylenol Tampering Investigation – 1987
• Three quality step increases for outstanding work performance – 1985, 1990, and 1992
• Numerous cash awards

TRAINING AND EDUCATION:

• Attended the Good Manufacturing Practices Conference at the University of Georgia – 1996, 1997, 1998, 1999, 2000, 2001, 2002, and 2004
• Computer System Validation Course – 2000
• Back to Basics – Fundamentals of Inspection – 2000
• Active Pharmaceutical Ingredients Manufacturing Course – 2000
• LAL, Sterility, and QA/QC for Inspecting Laboratories in the Pharmaceutical and Medical Device Industries Course – 1996
• Advanced Good Clinical Practices Training Course – 1995
• Pre-Approval Inspections/Investigations Course – 1992
• Advanced Pharmacology Course – 1987
• The Reid Technique of Specialized Interviews Course – 1987
• Pharmacology and Experimental Therapeutic Course – 1987
• Computer in Process Control Course – 1987
• Updated Food and Drug Law and Evidence Development Course – 1986
• Preparation of Parenteral Medications Course – 1985
• Industrial Sterilization for Drugs and Medical Devices Course – 1985
• Medical Device Manufacturing Quality Control Course – 1981
• Basic Food and Drug Law Course – 1980
• Basic Drug Manufacturing Course -1979
• Evidence Development Course – 1978
• Bachelor’s Degree in Education, Marshall University, Huntington, West Virginia, 1970

Edward M.

Senior Compliance Consultant

AREAS OF EXPERTISE:

Edward M. has more than 30 years of experience as a US Food & Drug Administration Investigator. He has broad experience in the pharmaceutical, medical device, and other industries regulated by the FDA. During inspections of pharmaceutical firms, a broad range of dosage forms have been inspected, including: tablets, capsules, powders (sterile and non-sterile), liquids, creams, ointments, SVP, LVP, APIs, and other dosage forms. Additional inspections of activities such as post-marketing surveillance, re-packaging or re-labeling, PDMA, Pharmacy compounding, and other programs have been performed.

EXPERIENCE SUMMARY:

The FDA Group, Worcester, MA

• Worked at a major pharmaceutical firm in Puerto Rico. Duties included: review and evaluation of production records, manufacturing and laboratory investigations; evaluation of the some of the firm’s Quality Assurance systems; acting as mentor to personnel who perform Manufacturing Investigations.
• Performed an audit of an API manufacturer in Italy dealing primarily with assessment and remediation of data integrity issues, and an assessment of their existing Quality Systems.
• Worked at 2 major medical device firms. Activities included assisting with preparation for evaluation of Clinical program at 1 firm, and group or individual participation in 6 mock audits at manufacturing facilities (3 domestic and3 foreign).
• Visited a mid-size drug firm for the purpose of evaluating and facilitating changes to a change control system, and evaluating manufacturing problems at a contract manufacturing site.

US Food & Drug Administration Investigator (1976-2006)

• More than 160 inspections of pharmaceutical firms have been performed in 9 states and several foreign countries.
• During inspections of pharmaceutical firms, a broad range of dosage forms have been inspected, including: tablets, capsules, powders (sterile and non-sterile), liquids, creams, ointments, SVP, LVP, APIs, and other dosage forms. Additional inspections of activities such as post-marketing surveillance, re-packaging or re-labeling, PDMA, Pharmacy compounding, and other programs have been performed.
• Approximately 150 inspections conducted of medical device firms, performed in 6 states. During inspections of device firms, a broad range of manufacturing processes have been inspected, including: mechanical, textile, plastic (extrusion or blow molding), electronic, radiological, in-vitro diagnostics, highly automated processes, contract sterilizers (radiation and ETO) and many sterile products (steam, ETO, or radiation sterilized). Inspections of medical devices have ranged from very simple to very complex (pacemakers and Positron Emission Tomography).
• In addition to extensive experience in the drug and device areas, a substantial number of inspections have been performed in the biologic, and bio-research (Clinical Investigator, sponsor, monitor and non-clinical labs) industries. At least 70 inspections in the Bio-Research area were performed for FDA.
• Positions held with FDA include:

• Investigator, Grand Rapids, MI, 1976-1985.
• Drug and Device Specialist, Salt Lake City, UT, 1985-1988. Work was concentrated in the Medical Device and Bio-research fields.
• Resident in Charge, and later District Drug Specialist in Knoxville, TN, 1988-2006. Work was concentrated in the drug, device and bio-research fields.
• Work with FDA has included several details as Supervisor, Compliance Officer, and numerous team inspections as either team leader or team member.

EDUCATION AND TRAINING:

• B.S. degree from Alma College, Alma, MI in 1973 with a major in biology and several minors. Additional college courses since graduation have included: 2 semesters of Organic Chemistry; 1 semester Psychology and 1 semester in basic Statistics as well as several correspondence courses.
• FDA Training related to Medical Device, Drug or Bio-research work, which may be relevant includes:Advanced Pharmaceutical and Experimental Therapeutics-8/83
  Basic Drug School-7/79
  Computer System Validation-4/95
  Drug Training Seminar-4/79
  Industrial Sterilization of Drugs and Devices-4/91
  Industrial Microbiology-5/88
  Introduction to Biotechnology-6/86
  NDA/ANDA Pre-approval inspection-7/92
  New Drug Pre-approval inspections-8/99
  Non-clinical Bio-research Monitoring-9/79
  Pharmacology-1/85
  Statistical Manufacturing QC-1/79
  Statistics (college course)-4/81
  Sterilization seminar-10/83
  Attendance/speaker at Univ. of GA GMP conference-3/02
  Active Pharmaceutical Ingredient Inspections (API)-4/04
  Process Validation for Medical Devices
  Design Control Training-8/97
  QSR Training Seminar-4/97
  Orientation to International Inspections-2/01
  Additional FDA training has been received in other types of inspections.
  Additional training has been received from the pharmaceutical and medical device firms audited during consulting. Such training typically includes an overview of their operations and their Quality Systems.

FDA AWARDS, COMMENDATIONS, AND ACHIEVEMENTS:

• Award Of Merit for being the lead investigator in an investigation of a large Infant Formula firm, which resulted in recalls and prosecution in 1982.
• Nashville District nominee in 1991 for the Patrick Pouzar, Investigator of the Year award (national award).
• Commissioner’s Special Citation for Excellence in 1991.
• Selected to accept a Group Recognition Award for bringing a major drug firm (Vintage) into compliance with GMPs (including Consent Decree), in 1999.
• Selection as a District Drug and Device Specialist in 1985, at the GS-12 Grade, by Denver District.
• Selection as a District Drug Specialist in 2000 at the GS-13 Grade, by Nashville (later New Orleans) district.
• Elected Drug Team Leader by the members of the Drug Team while the Nashville District operated on a Team Basis (as opposed to the traditional supervisor/employee relationship).
• Completion of the Training and Audit requirements for FDA Certification as a Level II Drug Investigator in 2005.
• Several additional awards or commendations have been received. Performance appraisals have routinely been excellent to outstanding resulting in quality step increases, special cash awards for specific pieces of work, and memorandums or other documents discussing the high quality of work.

Gurston T., PhD

Senior Compliance Consultant

AREAS OF EXPERTISE:

Dr. Gurston T. has more than 24 years of experience with the US Food & Drug Administration. His FDA experience includes pharmaceutical manufacturing, repacking, and compliance. He has broad experience in drug, medical device, clinical investigators, food, dietary supplements, and cosmetic inspections. He specializes in Drug cGMP, NDA/ANDA/DMF, and clinical investigator inspections.

EXPERIENCE SUMMARY:

The FDA Group, Worcester, MA

- Peformed an audit at a Clinical Research Organization (CRO) and identified areas of compliance and non-compliance. Primary focus was on checking trial documentation, preparing the staff on handling an FDA audit, and making recommendations on resolutions to the issues that were found.

US Food & Drug Administration Investigator (1976-2000)

• As a pharmacologist with FDA, he established priorities, reviewed and evaluated inspection reports of clinical investigators, sponsors and monitors that were conducted by the field inspectors of the FDA. Dr. Gurston T. coordinated inspections of clinical investigators and laboratories involved in specialized biopharmaceutic studies as well as evaluated the submitted reports, which compared the practice of clinical investigators, sponsors and monitors with applicable regulations.
• He directed the selection of clinical investigators for routine surveillance inspections, and he directed and participated in for-cause inspections, including foreign clinical studies. Dr. Gurston T. participated in cases, which were deemed particularly complex and precedent setting. Review of the inspection reports included evaluation of the sufficiency and adequacy of practices investigated to ensure that applicable regulations were being satisfied, that scientific soundness was maintained, and that adherence to scientific and administrative policies of the FDA were maintained.
• Dr. Gurston T. prepared summaries of the inspection or investigation and reviewed and submitted substantive recommendations and conclusions for approval by the FDA for the findings of such reviews. The recommendations submitted contained determinations on whether the requirements of applicable regulations have been met, and that the data covered by the audit were adequate. Dr. Gurston T. recommended administrative or legal sanction to the Regulatory Management Branch when serious violations of the law and regulations were discovered. In addition, Dr. Gurston T. assisted the Regulatory Management Branch in the development of such cases. He met with industry representatives to exchange information and provided advice and guidance regarding those aspects of clinical studies that are controlled by FDA guidelines.
• He reviewed and evaluated the results of preclinical pharmacological and toxicological studies submitted to the FDA in support of INDs and NDAs to assess the safety of a drug based on studies conducted by the applicant. Dr. Gurston T. reviewed the pharmacological data, which included evaluation of the sufficiency and adequacy of animal testing to ensure that the animal studies kept pace with clinical tests in INDs. He reviewed and evaluated NDAs focusing on preclinical animal data and evaluation of the toxicological potential of drugs when used according to the indications and dosage regimens in the labeling. This included evaluation of the toxicological potential on all organ systems, tissues and cells, and on the process of reproduction and on the offspring. Dr. Gurston T. prepared comprehensive summaries of the data reviewed and submitted substantive recommendations and conclusions for approval by his supervisors.

Theradex, Princeton Junction, NJ

As Director of Clinical Trials Integrity at Theradex, Dr. Gurston T. took part in field audits on oncology clinical trials both in North America and in the Theradex areas of overseas activities. In addition, he played an active role in Theradex’s in-service training programs.

Huntingdon Research Center, Becton Dickinson, Baltimore, MD

- As Manager of the Department of Chemistry for Huntingdon Research Center, Dr. Gurston T.’s primary function was to supervise personnel performing general analytical studies. Ongoing studies in chemistry included biomaterial testing of new plastic formulations, metabolism and pharmacokinetic studies on new drugs, residue analysis for chemical sterilants, and bioavailability testing of different drug formulations. This supervision included initiation and development of protocols suitable for the material that was being tested as well as analyzing and forming conclusions from the data generated.

• Dr. Gurston T. was also responsible for the management of a National Cancer Institute contract on the metabolism of tobacco smoke constituents. Dr. Gurston T. also acted as radiological safety officer for Huntington Research Center

Ortho Research Foundation, Raritan, NJ

As a scientist at Ortho Research Foundation, Dr. Gurston T. supervised two junior scientists in the metabolic pharmacology group.

University of Pennsylvania, Philadelphia, PA

As a Research Associate at the University of Pennsylvania School of Veterinary Medicine, Dr. Gurston T. delivered lectures on general physiology and endocrinology. Later work included development of methodology for measuring blood flow through the intact mammary gland.

• University of Maryland, Baltimore, MD
• U.S. Department of Agriculture, Washington DC
• U.S. Army, Asheville, NC

EDUCATION:

• 1965 Ph.D., University of Maryland, College Park, Maryland
• 1963 Master of Science, University of Maryland, College Park, Maryland
• 1951 Bachelor of Science, Delaware Valley College, Doylestown, Pennsylvania

PROFESSIONAL AFFILIATIONS:

• New York Academy of Science
• Society for the Study of Reproduction
• American Society of Animal Science
• American Association for the Advancement of Science

Jorge G.

Senior Compliance Consultant

AREAS OF EXPERTISE:

Jorge G. has more than 28 years of experience as a US Food & Drug Administration Investigator. During his career with the FDA, he acquired considerable knowledge of the overall mission and operation of that Agency. While with the FDA, approximately 50% of his inspections resulted in withholding or pending status of application approval. As a senior compliance consultant, he has assisted the pharmaceutical industry in preventing deficiencies, which could result in the withholding of application approval.

EXPERIENCE SUMMARY:

The FDA Group, Worcester, MA

Provides professional cGMP FDA inspection preparation services to manufacturers of active pharmaceutical ingredients, finished dosage, and parenterals. Services provided include mock inspections, cGMP audits, assessment evaluations, and training. He has assisted in preparation of NDA/ANDA, AADA, and NADA.

US Food & Drug Administration Investigator (1977-2005)

Promoted safety and efficacy of FDA regulated products through domestic and international inspections of FDA regulated industry. Broad inspection expertise in the following:

• Certified Level II Investigator
• Recruited as part of FDA CDER Inspectorate Team
• San Juan District FDA Headquarters Sampling Program Coordinator
• San Juan District Foreign Inspection Program Coordinator
• Pre-approval Manager
• Member of the Haitian Pharmaceutical Analysis Group (World Health Organization)
• New Hire Training Coordinator
• Reviewed and approved GMP inspection reports
• Foreign Inspections: Popular Republic of China, Israel, Japan, France, Italy, Sweden, Ireland, Switzerland, United Kingdom, Spain, France, Czech Republic, Haiti, Germany, India, the Netherlands, Portugal, and Belgium.
• Served numerous details as Compliance Officer, Supervisory Investigator and Director of Investigations Branch
• Inspection activity resulted in average of 60% actions (Warning Letters, Injunctions, etc.)

OTHER RELEVANT EXPERIENCE:

• EEO Counselor
• Black in Government Program Manager
• Hispanics in Government Program Manager

LANGUAGE SKILLS:

• English
• Spanish

HONORS AND AWARDS:

• 7 Letters of Commendation
• 4 Top Performer Awards, San Juan District
• Commissioner’s Special Citation in recognition of uncommon dedication and effectiveness in protecting public safety, 1883
• Hurricane Hugo Emergency Response Group Award (1990)
• Latex Glove Mass Seizure Award (1993)
• Major drug GMP Injunction Team Award (1994)
• Hurricane Hortense Emergency Response Group Award (1997)
• Haitian Pharmaceutical Contamination Analysis Group Award (1999)
• Foreign Inspection Cadre Awards (2002 and 2004)
• New Training Program Coordinator Award (2002)
• Drug GMP Training Program Award (2002)
• Pharmaceutical Sourcing Group Americas Award (2003)
• PSGA/FDA Cross Training Award (2003)
• Level I Investigator Certification (2004)
• Level II Investigator Certification (2004)
• FDA Pharmaceutical Inspectorate (2004)

EDUCATION AND OTHER EXPERIENCE:

• Criminal Investigator Certification, Department of the Treasury, Federal Law Enforcement Training Center (1980)
• BA in Biology, University of Puerto Rico (1977)
• Associate Degree, Civil Engineering, Puerto Rico Institute of Technology (1971)
• Individual course work in: Advanced Tablet 2 Capsule Technology (School of Pharmacy, University of Puerto Rico), Drug Management and Quality Control (Rutgers University), FDA Law and Evidence Development (University of Massachusetts), Blood Bank and Plasmaphereses Inspectional Techniques (American Red Cross), Food Microbiology (University of Wisconsin), Analysis of Pesticide Residue (P.R. Dept. of Agriculture), Chemical Instrumentation Techniques, Certified as Criminal Investigator (FLETC, Georgia, USA); Industrial Sterilization Drug and Devices, NDA/ANDA Pre-approval Inspections, Quality Audit for Improved Performance, FDA FAME Leadership Skills, API Training Course, Documentation Validation Activities among other several training courses at FDA ORA University Center in Maryland.

Jay C.

Senior Compliance Consultant

AREAS OF EXPERTISE:

Jay C. has more than 24 years of experience as a US Food & Drug Administration Investigator with more than 11 years of industry experience. His FDA experience includes pre-approval inspections of pharmaceutical manufacturers, non-clinical and clinical trials, and medical devices assessments with areas of expertise in sterile operations and computer controlled processes.

EXPERIENCE SUMMARY:

The FDA Group, Worcester, MA

Assist large and medium size pharmaceutical and biological manufacturing facilities in preparation for FDA pre-approval inspection, using a “mock FDA inspection” style. Critical evaluation of computer assisted manufacturing operations and computer assisted operations of non-clinical laboratories and computerized clinical trial operations. Assessments include manufacturing process controls, analytical chemistry and microbiology laboratories’ controls, procedure and policy controls, training. Regularly present a two-day course nationwide to FDA regulated industry representatives, titled “Conducting Internal Audits and Pre-Approval Inspections”.

nne pharmaplan, West Chester, PA

More than 4 years as senior compliance consultant performing Quality Assurance assessments of pharmaceutical manufacturing plants for compliance to cGMP regulations.

Aventis/Rhone Poulenc-Rorer, Collegeville, PA

Conducted International QA Audits of manufacturers of Finished Pharmaceuticals and Bulk Pharmaceutical Chemicals. Managed the PAI audit program for successful FDA approval of RPR’s two large NDA projects. Prepared sites for Pre-Approval Inspections and received successful approval of two major New Drug Applications (Synercid and Taxotere). Coached key site managers and production staff on Pre-Approval Inspections and on critical current Good Manufacturing Practice philosophies and skills by an integrated approach, using in-depth knowledge of regulatory practices. Developed corporate written procedures and assisted in development of corporate policies. Conducted supplier audits to assist domestic supplier audit staff.

US Food & Drug Administration Investigator (1972-1996).

Promoted safety and efficacy of FDA regulated products through domestic and international inspections of FDA regulated industry. Areas of specialty include sterile operations and computer controlled processes. Broad inspection expertise in the following:

• Pre-approval medical device and pharmaceutical inspections
• Non-clinical and clinical trials
• Institutional review boards
• Biological Products: Plasmapheresis & Blood bank operations
• Foreign commodity importation reviews
• Low-Acid thermally processed products
• Animal tissue residue investigations (FDA Program Manager)
• Resident in charge

CONTINUED

PROFESSSIONAL

DEVELOPMENT

Quality Systems Lead Auditor RAB C Programming Language

Validation of Biologics Autocad 13

Process Validation Computer Software Validation

EDUCATION:

Cal. State Fresno

Graduate study in Biology

TRAINING:

21 CFR Part 11 Electronic Records; Electronic Signatures, auditing system development and system maintenance, application to legacy systems and the systems development life cycle. Training provided by the firm that trains FDA inspectors and agents.

AFFILIATIONS:

Parental Drug Association

International Society for Pharmaceutical Engineering

American Society Quality Control

Regulatory Affairs Professionals Society

CERTIFICATION:

ISO 9001 Quality System Auditor

The following is a list of professional development courses completed:

Pharmaceutical and Experimental Therapeutics

Nonclinical Bioresearch Monitoring

Preapproval Drug Inspection

Clinical Supplies Packaging

Industrial Sterilization of Drugs/Devices

Drug Manufacturing Quality Control

Drug GMP Updates (annual)

DIA Conference

Compressed Medical Gas GMP

Biologics/Biotech:

Blood Bank & Plasmapheresis

Biotechnology Intro.

Validation of Biologics

Medical Device:

Medical Device Training

Quality Auditing ASQC

Medical Device Process Validation

Computer Systems:

Advanced Regional PC Training

C Language programming Level 1

Computer Use in FDA Investigations

Computers in Process Control

Train the Trainer –Investigating Computer Application

Computer Software Validation

DBase IV, Quattro Pro, Autocad 13FDA Law:

Acting Compliance Officer

Basic Food & Drug Law

Legal Aspects of Enforcement

Acting Compliance Officer

Management:

Pre-Supervisory Workshop

Acting Supervisor Investigator

Working Together for managers

EEO Awareness

Intro to Supervision

Ethics & Bribery Awareness

Communicating with the FDA

Report Writing

Veterinary:

Medicated Feed Inspection

Basic Food Technology

Foods:

Food Micro. & Sanitation Control

Control of Foodborne Disease

Current Concepts Food Protection

FDA/NCA Better Process Control

International:

Orientation to International Inspections

George C.

Senior Compliance Consultant

AREAS OF EXPERTISE:

George C. has more than 21 years of experience as a US Food & Drug Administration Investigator with more than 3 years of industry experience. His FDA experience as a level II certified medical device investigator includes pre and post approval inspections and investigations of domestic and foreign medical device manufacturers and other medical devices assessments with areas of expertise in total quality systems, design controls, CAPA, sterile operations, and computer controlled processes.

EXPERIENCE SUMMARY:

The FDA Group, Worcester, MA

Provides professional FDA inspection, compliance, quality, and regulatory preparation services to all sizes and types of manufacturers, repackers/ relabelers, specification developers, design houses, and sterilization companies which manufacture, label, distribute, design, and/or process all types of class I-III medical device products. Services provided include mock FDA QSIT, compliance, and for-cause inspections and investigations, QSR audits, assessment evaluations, and training.

Aerotek Scientific, LLC, Piscataway, NJ

Nine (9) months as a contract regulatory specialist for a NJ medical device and pharmaceutical dental manufacturer (confidential). Performed quality system and targeted internal audits of the pharmaceutical and medical device areas to assure compliance against company procedures, FDA laws and regulations, MDD, ISO 9001, and ISO 13485. Monitored and maintained CAPA and non-conforming product documents and operations. Conducted gap analyses of individual documents, processes, and logs associated with CAPA and non-conforming product reports, technical files, product labels, US/EU/Canadian product submissions and licenses, pharmaceutical NDC’s, and product recalls. Revised management review, CAPA, non-conforming product, MDR, and recall procedures. Prepared subsystem CAPA’s pertaining to internal and external findings associated with management controls (including quality plans, internal audits, and management reviews), design controls/ technical files, CAPA’s (including CAPA’s, non-conformances, complaints, and MDR’s), purchasing controls, change controls, laboratory operations, document controls, equipment and facility controls, product identification and storage, process validation, and process and production controls. Conducted out of specification investigations. Reviewed and critiqued medical device and pharmaceutical process validation studies and pharmaceutical reserve sample storage operations. Developed management control, design control/ labeling, CAPA, and purchasing control plans. Developed a ‘corrective action’ rework plan and procedure associated with a non-conforming medical device product. Provided technical support regarding design controls, change control, root cause analyses, corrections, corrective actions, and preventive actions.

Guideline/ Intota, Bloomington, MN

Five (5) months as a contract medical device quality litigation expert for two (2) separate legal clients (confidential). Analyzed, investigated, and reviewed associated production and design study documentation, labeling, and potential non-conforming combination pharmaceutical and medical device products. Analyzed, investigated, and reviewed depositions and associated MDR/ complaint, et al documentation pertaining to a potential non-conforming surgical medical device product. Both cases were settled due to these litigation analyses, investigations, and reviews.

Synthes, USA, West Chester, PA

Four (4) months as a medical device regulatory compliance auditor for a PA orthopedic implant company. Conducted mock/internal/external FDA QSR audits of domestic site manufacturing facilities, including supplier audits, within the medical device realm. Completed quality records (such as pertaining to CAPA validation/verification of effectiveness reports). Evaluated product designs and manufacturing processes for compliance with regulations. Performed onsite reviews of firm written procedures, processes, and operations and recommended corrections for continuous improvement. Established continuous process improvement at various levels at the organization. Experience in both the FDA field and headquarters offices to ensure compliance prior to FDA inspectional visits. Ensured that manufacturers’ employees have proper knowledge of applicable medical device laws, regulations, and standards. Developed and implemented business practices improving and reducing operating expenses of company sites (such as aiding in the creation of new device master records). Collaborated with site manufacturing personnel to gather information and explain findings. Advised firm officials on FDA enforcement policies. Conducted training sessions on inspection and investigation techniques and other related topics. Communicated with and maintained customer relations with facility personnel (such as during internal audits of other site locations). Significant experience in making group presentations to firm personnel pertaining to process validations and CAPA’s

Oxford International, Beverly, MA

One (1) month as a contract medical device quality consultant for a TX orthopedic implant company (confidential). Compiled data necessary to complete 21 CFR 803 MDR baseline reports. Reported to Quality and Regulatory management on bringing the MDR processes and product 510(k)/PMA files into FDA compliance for various class I/III orthopedic implants and accessories.

New World Regulatory Solutions, Inc. Tom’s River, NJ

Four (4) months as a contract international medical device consultant for a UK in-vitro diagnostic manufacturer (confidential). Audited the QSM, Manufacturing, DHF deliverables for consistency and conformance with all FDA laws and regulations. Reviewed the current Risk management Plan, and all related deliverables. Recommended and setup management controls, design controls, CAPA and process validation protocols and Production Processes as part of the Quality Initiative Program. Audited, reviewed, and critiqued Vendor and Supplier Mfg process SOP’s, data and deliverables for accuracy, completeness, and Quality. Reported to the CEO and VP’s for recommendations on bringing the Manufacturing, Quality, Supply Chain and Design/Manufacturing processes and procedures into FDA compliance for a Class III PMA IDE IVD.

US Food & Drug Administration- Analyst and Investigator (1985-2006).

Analyzed, food, cosmetic, and drug samples as an analyst. Promoted safety and efficacy of FDA regulated products through domestic and international inspections of FDA regulated industry as a Level II Certified International Medical Device Investigator. Areas of specialty include medical device design controls, CAPA, sterile operations and computer-controlled processes. Conducted routine inspections of domestic and foreign manufacturing facilities and investigated consumer complaints related to FDA-regulated products, primarily within the medical device industry. Evaluated product designs and manufacturing processes for compliance with regulations. Performed and documented numerous inspections, achieving enhanced compliance through various regulatory actions including warning letters and seizures. Established continuous process improvement at all levels in organization. Ensured that manufacturers’ employees have proper knowledge of applicable regulations. Developed and implemented business practices improving and reducing operating expenses. Collaborated with manufacturers’ personnel to gather information and explain findings. Initiated legal actions against violators. Advised industry, state, and local officials and consumers on enforcement policies. Conducted training sessions on inspection and investigation techniques and other related topics. Communicated with and maintained customer relations. Served as medical device team leader on complex assignments requiring the participation of multiple personnel. Fulfilled the duties of the Resident-In-Charge during an extended period of absence. Demonstrated skills in preparing comprehensive and easily understood written communications. Fostered team spirit and open communication on all phases of business. Developed approaches and procedures, which have improved the efficiency of agency operations. Extensive background in the enforcement of consumer protection regulations. Thorough knowledge of all provisions of the Federal Food, Drug, and Cosmetic Act. Experience in both the field ensuring FDA compliance as well as in the headquarters office. Worked (internal detail positions) as a field compliance officer (Detroit District), FDA HQ international medical device inspection planner (ITOB- International and Technical Operations Branch), and FDA HQ International compliance officer assisting international companies and other federal agencies about FDA laws, regulations, standards, product labeling, etc. (IRIS- International Regulatory Issues Staff). Was Detroit District Medical Device Team Leader and Co-Leader – Indiana.

Broad inspection expertise in the following:

• Domestic and foreign pre-approval 510(k) and PMA medical device inspections.
• Medical Device QSIT inspections and investigations.
• Pharmaceutical cGMP inspections and investigations.
• Plasmapheresis & Blood bank GMP inspections and investigations.
• Foreign commodity importation reviews.
• Low-Acid thermally processed products.
• Animal tissue residue investigations.

RECOGNITION AND AWARDS:

• Detroit District Award- Special Act or Service Award for willingness to provide assistance to District coworkers whenever needed- 3/11/2001
• Madison Who’s Who Lifetime Quality Member- 2008
• International Who’s Who Member of the Year-1998
• Detroit District Award- International Inspections/Knowledge- 8/1998
• FDA Group Recognition Award- Office of Policy- Framework Agreement with the European Community on the Equivalence of Veterinary Products- 5/8/1998
• Device Pilot Program Tracking Team Award- 11/1996
• Midwest Region FY ’96 Goal Champion Award- 6/27/1996
• Detroit District Hip Implant Team Award- 7/1995
• Detroit District Quarterly Award- Biologics Team- 3/1995
• Indiana Medical Device Manufacturers Council Honors for a speech given to IMDMC members- 8/6/1993
• Detroit District Employee of the Month- 2/11/93
• CASA Pittsburgh Chapter Vice-President- 1987-1988

PRESENTATIONS:

• Co-author of Abstract Paper- “Use of Surfactants In Dissolution Studies of Water Insoluble Drug Products: Carbamazepine and Metolazone” – 1986
• Medical Device Speaker at Indiana Medical Device Manufacturer’s Council.
• FDA Speaker at various high schools and colleges.

EDUCATION:

• 2006- present: Doctor of BA, Northcentral University, Concentration in International Business, est. 2010, completion (Online Study- in progress)
• 1991-1999: MBA – Indiana University, Concentration in International Business
• 1984-1989: BS – Metallurgical Engineering, University of Notre Dame
• 1978-1982: BS – Chemistry, University of Notre Dame

CERTIFICATION:

Level I/II Certified Medical Device Investigator

REGULATORY EXPERTISE:

All Types of Class I/III Medical Devices, Including Electronic, Mechanical, and Non-mechanical Medical Devices- Durable, Electronics, Implantables, IVDs, Lasers, Software, Cataract systems, Oncology systems, Coated Stents, Steerable Catheters, Over the wire (OTH), Rapid Exchange (RX) Stent delivery systems (STS), Pacemakers, Tracheostomy Tubes, Sterilized Devices, and Orthopedic Implants. Adverse Event Evaluation, Audits -Certification/Due Diligence/ GCP/ GLP / ISO/Quality System Inspection Technique (QSIT)/ Quality System Regulation (QSR), Clinical Labeling / Research/ Study design, Electronic Records & Electronic Signatures; 21 CFR Part 11, FDA, FDA – 483 and Warning Letter Responses/Consent Decree, GAMP, Hazard Analysis, ISO – 13485/ 9001/9002/ 9003/14971 (Risk Management)/ Active Implantable Medical Device Directive (AIMD) / In-vitro Diagnostic Directive/ Medical Device Directive (MDD), OSHA, Quality Assurance, Quality Control, Quality Management, Quality Systems Development/ Implementation, Working Knowledge of FDA Operations.

TRAINING:

Computer training includes: 21 CFR Part 11 Electronic Records; Electronic Signatures, auditing system development and system maintenance, application to legacy systems and the systems development life cycle.

Other training is listed below.

The following is a list of professional development courses completed while at the FDA:

Medical Device Training

Quality Auditing for Improved Performance ASQC

Medical Device Process Validation

FMEA Workshop

QSIT Device Training

Medical Device Auditing

Medical Device Workshop

Industrial Sterilization for Drugs and Devices

Intro to Bio Research Monitoring

Medical Device Team Leader/ Co-Leader

Drugs:

Drug Manufacturing Quality Control

Compressed Medical Gas GMP Workshop

Biologics/Biotech:

Blood Bank & Plasmapheresis

Apheresis Training Seminar

Computer Systems:

Computer Systems Validation

VAX System Training

Personal Computing

Computer Aided FDA Inspections

FDA Law:

Basic and Update Food & Drug Law and

Evidence Development

Investigative Interviewing

Acting District Compliance Officer

Teambuilding:

Team Building Initial/Follow Up Workshops

Diversity Awareness Workshop

Myers-Briggs Type Indicator Team Building

Sexual Harassment Prevention Training

Investment in Excellence Initial/Follow Up

Veterinary:

Medicated Feed Inspection

Tissue Residue

Basic Food Technology

Foods:

Food Microbiological & Sanitation Control

Seafood Inspection

LACF Food Presentation Seminar

Hazard Communication

International:

Orientation to International Inspections

Acting Medical Device Trip Planner- ORA

Acting International Compliance Officer-IRIS

Laboratory:

Modern Analytical Methods

Len V.

Senior Quality Compliance Consultant

AREAS OF EXPERTISE:

Extensive experience and knowledge achieved through a distinguished 30-year FDA career. Accomplished a comprehensive multidisciplinary background in the Field and FDA Center Offices
including ORA, CDER, CFSAN, CDRH, CVM, and the Office of the Commissioner. Career positions include operating in FDA’s critical mission functions as chemist, compliance officer, and international policy analyst. Accomplishments show proven experience and dedication to FDA’s mission by progressively reviewing new drugs, and effectively orchestrating FDA’s headquarter enforcement strategies with drugs, biologics, foods, medical devices, and veterinary medicine. Originated and developed innovative approaches risk based pharmaceutical quality, laboratory testing standards, bioterrorism preparedness, and strategic importation enforcement policy. Facilitated Agency direction with technology transfer, global harmonization to allow collaboration of GxP with foreign regulatory authorities. Retained as a government expert witness.

EXPERIENCE SUMMARY:

Industry Consultant, Glen Burnie, MD

Senior Quality & Compliance Consultant 2006- present

I have been working with domestic and international firms providing comprehensive technical, regulatory, and compliance services to remediate and ensure clients they are confident conforming to FDA policies and Regulations associated with GxP’s, QSR, HACCP, QSIT, ISO/IEC standards, and foreign regulatory requirements. I have consulted to the pharmaceutical, biotechnology, medical device and clinical laboratory industries advising clients on issues involving quality and regulatory compliance and risk management operations. In addition evaluates Accrediting bodies including NIST/NVLAP to conformance ISO/IEC 17011& 17025.

Project Achievements for Clients

• Resolved FDA compliance issues for GxP’s
• Remediate and prepared responses to FDA 483’s and Warning Letters
• Prepared regulatory impact analysis for Wall Street firms including assessments for M&A’s and financial impact with FDA’ regulatory action. Regularly assists company management in developing compliance audit programs, executing audits, assessing results and implementing timely and effective corrective and preventive actions

• Competent auditing to ISO/IEC 14385 for competency of medical device manufacturing and ISO/IEC 15189 for medical device testing
• Supply chain strategies bulk, components and sterile finished products involving RFID, dental, In-vitro diagnostic devices
• Performed and provided guidance for due diligence assessments involving the acquisitions of pharmaceutical, medical device, and food processors facilities
• Performed numerous gap analysis on the adequacy of Quality Management Systems, and deviational systems for 21 CFR Parts 58, 110-111, 210-211, 225, 510, 803, 806, 807, 820, (PHS Act) 1271 and CGTP requirements
• Provided IQ, OQ, PQ requirements/traceability, evaluated assessments, revised protocols and procedures, prepared reports for establishing criteria for process validation
• Evaluated numerous validation reports, manufacturing records and device file records for compliance, quality, and efficiency improvement for sterile and non-sterile products
• Performed numerous audits of computer system 21 CFR Part 11 system compliance gap assessments and reporting
• Experience with aseptic, steam, ETO, and gamma radiation sterilization treatments used in food, biopharmaceutical and medical device manufacturing
• Provided numerous audit for Class 1, 2, and 3 Medical devices and Biological combination
• Develop, prepare, validate, and evaluate the adequacy of CAPA’s and provide effective metrics for root cause. Including discerning determination MDR reporting
• Prepare facilities, provide training and perform simulated FDA mock audits for drugs, biologics, medical devices using human tissue and GLP CMC changes for NDA’s and ANDA’s
• Clinical readiness audits
• Importation assistance for FDA regulated products
• Provide Establishment Registration and listing service for dietary supplements, OTC Drugs and medical devices.
• US Agent designate for foreign firms for pharmaceuticals and foods imports
• Reviewed conformity of human tissue based products for implant and combination biologic/devices
• Sterility processes pharmaceuticals, medical devices and biologics
• Craft labeling for foods, dietary supplements, OTC drugs, medical devices and cosmetics

FDA, Office of the Commissioner, Rockville, MD

Office of International Programs
International Affairs Policy Analyst, North American Desk, 2003 -2006

Project manager to coordinate and exchange information with foreign governments territories covering Canada, Mexico, Caribbean and Latin American countries pertinent to trade. Provided a communication conduit, discretionary disclosure (21 CFR Part 20), to allow for the scientific exchange of clinical data to collectively collaborative for the advancement of science for new drug review. Coordinated with foreign authorities to allow investigations of potential sources of food borne illness. Assisted foreign governments clarify requirement of FDA’s policies for the importation of regulated products. Leveraged resources to enhance and reduce duplication of FDA foreign investigations in countries with have similar regulatory schemes for coordination of market access and approval. Maintained diplomatic relationships with foreign regulatory colleagues to support shared public health goals. Develop recommendations for harmonizing the sanitary and phytosanitary measures (SPS) and technical barriers to trade (TBT) and certification bodies, and laboratories.

• Assisted in trade capacity building for Western Hemisphere countries and organizations.
• Contributed in developing a strategic risk targeted import safety system for FDA regulated products.
• Authorized Emergency Export of unapproved drugs and biologic clinical studies for export for investigation in foreign countries.
• Coordinated epidemiological studies with foreign governments; orchestrated multi-international investigations and recalls.
• Assisted in collaborating bilateral investigations of foreign firms for drugs and medical devices.
• Contributed in developing Prior Notice regulations and guidance on Bio-terrorism regulations and prior notice.
• Coordinated State Department communications with FDA organizational units.

FDA, Center for Veterinary Medicine, Rockville, MD

Office of Compliance, Division of Enforcement
Team Leader Enforcement and Regulatory Guidance, 2002- 2003

Supervised 8 employees, including 2 Veterinarians and 6 compliance officers. Responsible for the enforcement and providing regulatory guidance involving post-marketed veterinary products under of the Center’s program area. Responsibilities included reviewing compliance officers work to assure that the evidence gathered was supportable for regulatory action including recommendations seizure, consent decree, import detention were appropriately scientifically supported. Tasks included coordination with USDA/APHIS/FSIS, State Boards to clarify prescription use, BSE and certification of herds by Veterinary Services. Provided and handled consumer inquiries, consumer complaints regarding pet foods.

Key Achievements

• HHS Secretaries Distinguished Service Award for outstanding leadership in FDA’s counter bioterrorism preparedness.
• Agency Committee member for Risk-Based Pharmaceutical Quality.
• Developed Agency enforcement procedures and regulations for Bioterrorism Act of 2002.
• Project management of Field compliance programs involving establishment inspections, medicated feeds under State contract, and BSE surveillance.
• Developed the first consent decree enforcement action for failure to comply BSE (Mad Cow) regulations.
• Processed 100% of enforcement cases involving the compliance of drug compounding, tissue residues, BSE, and labeling.

FDA, Office of Regulatory Affairs Rockville, MD,

Office of Regional Operations, Division of Field Science
Scientific Coordinator –laboratory accreditation private laboratory and food safety standards,
1999–2002

Performed laboratory QA Audits of FDA laboratories. Managed Field laboratory quality assurance program check sample program, and developed standard operating procedures for FDA Laboratory operations in Headquarter laboratories, Field Laboratories, and in District Offices for sample collecting and integrity.

Served as contracts/grants coordinator for purchasing laboratory instrumentation and securing drugs for post marketing surveillance. Developed and crafted policy documents for privately laboratory submissions; “Guidance on the FDA Review of Analytical Data Generated by Private Laboratories”. Planned, orchestrated, managed, monitored FDA Field methodologies to provide the technological transfer of new, improved and validated methods suitable for regulatory analysis, including food safety
and defective applications.

Key Achievements

• FDA Award of Merit for leadership and innovation in conjunction with the Presidential Initiation of the Safety of Imported Food.
• Led laboratory/industry discussion groups for OOS policy guidance.
• Credentialed Evaluator certified to conduct ISO/IEC 17058 laboratory accrediting body evaluation audits and 17025 assessments of testing laboratories in food testing scope.
• Developing a risk-based testing strategy for post-market surveillance of pharmaceuticals.
• Utilized methods to allow technology transfer of microanalytical techniques to detect bovine material in feed and food, from BSE affected countries.
• Course advisor/trainer for sensory analysis of decomposed seafood to attenuate organoleptic analysis.
• Developed sourcing with Department of Veteran Affairs for drug stockpiling and reuse of expired drug in the event of disasters.

Center for Devices and Radiological Health, Gaithersburg, MD

Office of Compliance, Division of Enforcement II,
Compliance Officer, General Hospital and personal use devices 1995–1999

Tasked to provide regulatory guidance and consultation regarding the classification and compliance of general hospital devices, HIV barriers, latex gloves, sterilizers, infusion pumps, lamps, linear accelerators, and prescription software validation. Advised industry, State, local officials, and consumers on medical device requirements and provided interpretation of regulations. Communicated during inspections to guide and develop evidence and investigation methods and procedures necessary to accomplish compliance/enforcement/regulatory objectives in the areas. Evaluated foreign inspectional observation and determined establishments’ adherence to Quality System Regulations, MDR regulations. Prepared Warning Letters to foreign medical device manufacturers when required. Administered questions and provided guidance on program area regulations and policies. Coordinated the review process of 510(k)’s and PMA to ensure compliance with GMP’s. Prepared recommendations for medical device establishment inspection compliance programs.

Key Achievements

• Evaluated and resolved compliance matters and device issues involving imported and domestic general hospital devices.
• Compliance representative for the FDA General Hospital Advisory Boards.
• Reviewed device quality systems, establishment inspection reports (EIR) and process validations.
• Responsible for the quality of all enforcement activities, and evaluation of the adequacy of firms’ quality systems concerning general hospital equipment and medical equipment for personal use.
• Processed injunctions that resulted in consent decrees of permanent injunction and/or fines against device manufacturers re: deviations from the CGMP requirements of the Quality System (QS) regulation, i.e., Siemens linear accelerators and sterilizers manufactured by foreign manufacturers.
• Processing of Warning Letters for sterilizers, sterile devices, infusion pump seizures, latex gloves, IV sets, and antiseptics.
• Evaluation of device manufacturing compliance with FDA’s QSR, Medical Device Reporting (MDR) regulation, and reports for Correction and Removal (CARS) (Complaint reports).
• Develop, prepare, validate, and evaluate the adequacy of FDA compliance with 21CFR Part 820, 21CFR Part 803 and 21 CFR Part 806, for medical device manufacturing and controls FDA recordkeeping requirements (MDR), and reports of Correction and Removal (CARS) (Complaint reports).
• Drafted medical device guidance involving medical software and software used for clinical research.

Center for Food Safety and Applied Nutrition, Washington, DC

Office of Compliance, Division of Regulatory Guidance, Import Food Safety Team
Compliance Officer 1990–1995

Evaluated and resolved compliance matters involving the importation of foods and dietary supplements associated with adulteration due to sanitation, chemical residues, microbiological contamination, GMP’s and labeling.

Determined compliance and guidance on regulatory requirements to ensure safety in foods, cosmetics, indirect additives, dietary supplements, and affirmed GRAS status for food additives. Determined the adequacy of GMPs, labeling, food additives, and sources of contamination for processed food. Evaluated and determined the compliance status of import detentions and inspection reports (EIR) involving microbiological hazards, LACF, pesticide residues, filth and misbranding. Presented workshops to industry, foreign governments, and consumers on the FDA requirements for FDA import requirements. Processed health hazard toxicology reports for food recall.

Key Achievements

• Originated the import detention of ephedrine as a dietary supplements.
• Reviewed and implemented HACCP for Seafood compliance program, food establishment inspection reports (EIR) and process validations for potential regulatory action
• Presented Compliance Inspector training for Food Microbiological Control at the University of Wisconsin.
• Determined phytosanitary requirements for USDA/APHIS/FDA, as a safeguard to prevent microbiological contamination of vibrio cholera, during the South American Pandemic.
• Processed precedent-setting injunctions of Importer brokers that sold adulterated products.
• Coordinated inspections and epidemiological investigations with CDC, USDA for Eggs.
• Processed of seizures for foods containing, Salmonella Enteritis, E. Coli O157:H7
• Collaborated and coordinated with Canadian Food Inspection Service to ensure that seafood products were properly processed to avoid contamination with Listeria monocytogenes.
• Reviewed mandatory labeling requirements for foods and dietary supplements.
• Authorized Certificates of Free Sale for export.

Center for Drug Evaluation and Research, Rockville, MD

Office of New Drugs, Division of Generic Drugs, Review Branch 1
Chemist – Reviewer Chemistry, Manufacturing and Controls, 1985–1990

Served as the recognized scientific expert, for training new chemist reviewers. Performed in-depth scientific reviews for the analysis, validation, and characterization of the chemical compositions and physical properties of drugs, antibiotics, chemicals, immunogenic agents, biological products. Conducted detailed scientific reviews of the chemistry, manufacturing, and controls for sterile and non-sterile generic drugs within statutory time frames. Gave guidance to applicants for drug approval concerning stability protocols, master formula records, vendor qualifications, method validations, and process validations for scale up. Reviews supported and defended appropriate drug formulation, processing, packaging and labeling to ensure safety and efficacy. Contributions include several policy-crafting CDER committees, stability, container closures and API characterization: Chemistry and Manufacturing Controls Coordinating Committees (CMCCC), prepared policy and procedure guides (PPG’s).

Key Achievements

• Originated the import detention of ephedrine as a dietary supplements.
• Reviewed and implemented HACCP for Seafood compliance program, food establishment inspection reports (EIR) and process validations for potential regulatory action
• Presented Compliance Inspector training for Food Microbiological Control at the University of Wisconsin.
• Determined phytosanitary requirements for USDA/APHIS/FDA, as a safeguard to prevent microbiological contamination of vibrio cholera, during the South American Pandemic.
• Processed precedent-setting injunctions of Importer brokers that sold adulterated products.
• Coordinated inspections and epidemiological investigations with CDC, USDA for Eggs.
• Processed of seizures for foods containing, Salmonella Enteritis, E. Coli O157:H7
• Collaborated and coordinated with Canadian Food Inspection Service to ensure that seafood products were properly processed to avoid contamination with Listeria monocytogenes.
• Reviewed mandatory labeling requirements for foods and dietary supplements.
• Authorized Certificates of Free Sale for export.

Center for Drug Evaluation and Research, Rockville, MD

Office of New Drugs, Division of Generic Drugs, Review Branch 1
Chemist – Reviewer Chemistry, Manufacturing and Controls, 1985–1990

Served as the recognized scientific expert, for training new chemist reviewers. Performed in-depth scientific reviews for the analysis, validation, and characterization of the chemical compositions and physical properties of drugs, antibiotics, chemicals, immunogenic agents, biological products. Conducted detailed scientific reviews of the chemistry, manufacturing, and controls for sterile and non-sterile generic drugs within statutory time frames. Gave guidance to applicants for drug approval concerning stability protocols, master formula records, vendor qualifications, method validations, and process validations for scale up. Reviews supported and defended appropriate drug formulation, processing, packaging and labeling to ensure safety and efficacy. Contributions include several policy-crafting CDER committees, stability, container closures and API characterization: Chemistry and Manufacturing Controls Coordinating Committees (CMCCC), prepared policy and procedure guides (PPG’s).

Key Achievements

• Successfully reviewed the top 200 prescribed generic drugs to U.S. consumers.
• Presented special recognition as recipient of the Public Health Service Award, as a member of the Abbreviated New Drug Application Group.
• Recognized for the leadership in implementing the Drug Price Competition and Patent Term Restoration Act, which established the modern system of generic drugs.
• Developed internal training programs and tools for the review of generic drug.
• Reviewed the identity, quality, purity, strength and the bioavailability of new drugs for approval, including sterile and non-sterile dosages.
• Reviewed to determine equivalency to standards set by the innovator drugs associated with the chemistry, manufacturing and controls (CMC)’s for the submission of ANDA’s, DMF’s and Citizen Petitions.
• Selected the most unusual complex dosage forms including transdermal patches, sustained-release products, sterile dosages and unique drug delivery systems.
• Selected by the FDA Commissioner to review generic drug applications for approval due to emergency drug shortages.
• Developed authoritative analytical methods for use in health assessments; designs new sampling and sample preparation procedures, protocols; validation and collaborative studies to ensure safety and efficacy.
• Originated the guidelines for the Characterization Active Pharmaceutical Ingredients (API), which includes the determination of particle sizes with APIs. Developed CMC drug quality guidance standards for solid dosage forms, and developed reviewing criteria for sustained- release drug products.

FDA Office of Regulatory Affairs, New York Regional Laboratory, Brooklyn, NY

Pharmaceutical Laboratory 1
Analytical Chemist, 1977–1985

Responsible for quantitative and qualitative annoys for the elucidation of a wide variety of drugs, foods, cosmetics, and medical devices to determine compliance with FDA regulations. Area of specialized experience was in the area pharmaceutical analysis and successfully developed validated methods. Analytical work was always credible to substantiate evidence to support investigational observations. Performed research and collaborated on methods development to support FDA’s mission. Utilized many analytical instrumentation techniques as well as micro analytical techniques.

Key Achievements

• Developed evidence for enforcement by laboratory worksheet documentation to ensure accountability credibility, and accuracy of results.
• Evaluated bioavailability-testing laboratory practices in pharmaceutical establishments on team inspections.
• Prepared and collaborated journal articles, FDA laboratory information bulletins for research purposes.
• Presented findings at professional meetings.

EDUCATION & CREDENTIALS

Long Island University, C.W. Post College
BS Chemistry

Greenvale, NY

Including study concentrations for math and physics.
Studies include 44 Credits towards a Masters in Public Administration.

30 years of FDA on-the-job training, Courses offered by FDA. Tasked to be a teacher to train employees
in processing chemistry reviews, regulatory actions, and methods to developed evidence.

• Trained ISO/IEC 17011:2004 National Cooperation for Laboratory Accreditation (NACLA) ISO/IEC 17011, Requirements for accreditation bodies accrediting conformity assessment bodies.
• Certified Evaluator Auditor ISO / IED Assessor 17025: 2005 Conformity assessment — specialized in food testing Scope.
• Audit to ISO/IEC 13485 ISO 13485:2003 Medical devices, Quality management systems, Requirements for regulatory purposes.
• Audit to ISO/IEC 17025 Competency for laboratory analysis.
• Audit to ISO/IEC 15189 for medical device testing.

PROFESSIONAL MEMBERSHIPS, ORGANIZATIONS AND PUBLICATIONS

Publications

• Presentation on behalf of FDA, Future U.S. initiatives Regarding Food Safety e. Coli a case history,” CRAAQ Horticultural Week 2007 Quebec” February 7, 2007
• Chemical & Engineering News, 85(39), September 24, 2007, Food Import Woes Weigh On FDA, interview with Linda Wang
• Pharmaceutical Quality for the 21st Century A Risk-Based Approach Progress Report, May 2007
• FDA, Laboratory Operations Manual Chapter 21, Guidance on the Review of Analytical Data Generated by Private Laboratories, November 1999
• J Assoc. Off. Anal. Chem. 1985 May-Jun; 68(3): 529-32. Reverse phase liquid chromatographic determination of bisacodyl in dosage forms. Valenti LP, Lau-Cam CA.
• Modern Methods of Plant Analysis, New Series Volume 8 , ISBN 3-540-18380, Analysis of nonalcoholic Beverages, Liquid chromatographic determination of quinine, hydroquinine, saccharin, and sodium benzoate in quinine beverages”, Valenti, L.P.
• FDA Laboratory Information Bulletin, “Microcrystalline detection of cyanide and over-the-counter drugs”, J.R. Ferfoglia & L.P. Valenti, May 1983
• J Assoc. Off. Anal. Chem. 1985 Jul-Aug; 68(4): 782-4.Liquid chromatographic determination of quinine, hydroquinine, saccharin, and sodium benzoate in quinine beverages”, Valenti, L.P.
• FDA Laboratory Information Bulletin # 2843, “PMR Detection and Determination of Dihydroquinine in Quinine”, R.M.Turksan & L.P.Valenti, 1982
• FDA Laboratory Information Bulletin, “Determination of Dirperodon Hemorrhoid Rectal Ointment by HPLC”, L.P. Valenti, 1978
• FDA Laboratory Information Bulletin, Determination of Quinine in Soft Drinks, Valenti, 1978

Member of Regulatory Affairs Professionals (RAPS)
Charter Member of the FDA Alumni Association (FDAAA)
Ignatius Volunteer Corps
Capital Area Food Bank – Food Safety SME, audits,
DC Central Kitchen – HACCP Planning, Inspection and Training

Michael E.

Senior Compliance Consultant

AREAS OF EXPERTISE:

Michael E. has 29 years of experience with the US Food & Drug Administration. His FDA experience includes 20 years of international cGMP drug product inspections, API inspections, GLP inspections and clinical data audits. He has broad experience in most areas of FDA regulation, including foods, drugs, medical devices, bio-research monitoring, dietary supplements, and cosmetics. He specializes in Drug Product and API cGMPs, NDA/ANDA/DMF reviews, clinical trial audits, and GLP audits.

EXPERIENCE SUMMARY:

The FDA Group, Worcester, MA

Since his retirement from FDA in 1994 he has been performing work in the following general areas:

• Active Pharmaceutical Ingredients (APIs): supplier audits & preparing manufacturing sites for FDA inspection. (Note: While with the FDA, he performed more than 100 API inspections, in approximately 20 countries).
• Finished Pharmaceuticals / Biologics: cGMP, QA, regulatory, and NDA work. Most of his consulting work has been in the pharmaceutical cGMP area. He has consulted for seven (7) pharmaceutical firms who have been under Consent Decree, and has performed a variety of auditing and other consulting work related to the pharmaceutical industry, both in the U.S. and in foreign countries.
• Veterinary Drug GMPs: General cGMP work including writing SOPs, improving batch records, assisting firm with response to FDA 483s & Warning Letters.
• Medical Device GMPs (Including manufacturing and clinical facilities).
• Clinical Studies: Audits of Clinical Study Sites, Contract Research Organizations, Sponsor/Monitor activities, Clinical Laboratories, and Phase-1 facilities.

His clinical consulting experience includes the monitoring of clinical sites for two major NDA projects. One of these involved the monitoring of clinical sites throughout Europe, the training of study monitors, representing the sponsor in a meeting with the FDA to discuss the audit results, and representing the sponsor during the FDA audit of selected sites, which he had previously audited, and which he correctly anticipated the FDA would audit. The project was successfully concluded with FDA approval of the NDA.

The other major project involved the auditing of domestic clinical study sites, preparation of the contract manufacturing and contract packaging sites (in Europe) for FDA pre-approval inspections, and the training of clinical study monitors. This project was successfully concluded with FDA approval of the NDA, which was reported as a cover story by Time magazine. The pre-approval inspection of the contract manufacturer resulted in no (zero) FDA-483 observations.

In addition to the two major projects described above, he has been involved in a number of smaller projects, including the training and re-writing of monitoring SOPs for a sponsor company, the training of monitors for a sponsor company, and various other regulatory-related projects in the clinical area.

He was also involved in a third party audit of a phase-one clinical facility, with two other independent consultants. FDA had agreed to the third-party audit after the FDA inspection had found possible fraudulent practices. The follow-up audit demonstrated that the practices in question did not constitute fraud, but were errors resulting from inadequate training.

• Other work related to NDAs/ANDAs, including preparing manufacturing sites for FDA pre-approval inspections.
• GLP Training: He has performed audits of GLP facilites and in Jan 2002 began working with Dr. Kenneth Cleaver, conducting GLP training courses for the Center for Professional Advancement. These were 3-day courses covering all aspects of the GLP regulations. They conducted two courses each in Boca Raton, FL, Amsterdam, San Francisco, and New Brunswick, NJ during two successive years.
• Peformed an audit at a Clinical Research Organization (CRO) and identified areas of compliance and non-compliance. Primary focus was on checking trial documentation, preparing the staff on handling an FDA audit, and making recommendations on resolutions to the issues that were found.

1972 – 1994: Investigator, U.S. Food & Drug administration, Detroit District, Grand Rapids Resident Post, Grand Rapids, MI

Performed work in a variety of industries, including foods, infant formula, blood banking & plasmapheresis, biologics, medical devices, pharmaceuticals, and inspections in FDA’s bioresearch monitoring program. In 1975/1976 participated in a lengthy audit of animal studies at the G. D. Searle Co., which led to the promulgation of the GLP regulations, and for which he received the FDA Award of Merit, the agency’s highest honor award.

In 1974 began doing foreign inspections, primarily with new drug substances and antibiotics. During his 20 years of participation in the foreign inspection program he inspected Active Pharmaceutical Ingredient (API) and Drug Product manufacturers in 20 countries, including the first FDA inspection in Turkey. Some of these inspections were pre-approval inspections of both drug products & APIs. The number of API inspections performed during his FDA career totaled more than 100. His foreign experience included a variety of dosage forms including injectables, soft gelatin capsules, hard capsules, tablets & several unique dosage forms.

His foreign work also contained a number of GLP inspections and a number of Clinical Study audits, including the first FDA audits of clinical studies in Japan. For the Japan audits, he was accompanied by Dr. Gurston Turner, a Pharmacologist with FDA’s Clinical Division. Mr. Erspamer has audited clinical studies in England, Scotland, Germany, Belgium, the Netherlands, Japan, and the U.S. Some GLP inspections conducted in England were done jointly with the British Ministry of Health, to aid the FDA in developing a Memo of Understanding with the British government. He also accompanied Japanese GLP inspectors who were conducting inspections of contract GLP laboratories in the United States.

In Sweden, he conducted drug pre-approval inspections accompanied by representatives of the Swedish government & FDA headquarters personnel to aid the Swedish authorities in conducting pre-approval type inspections under our Memo of Understanding with that country.

Prior to embarking on a trip to Japan in April 1980 he was asked to write an article about the trip for publication in FDA Consumer magazine. The article was subsequently published in the July-August 1980 issue.

During the last 15 years of his FDA career he specialized in the pharmaceutical area, along with inspections under FDA’s bioresearch monitoring program (Pre-clinical Studies, Clinical Studies, Institutional Review Boards, and Sponsor/Monitor inspections), with some medical device work. His pharmaceutical inspections included both NDA & ANDA pre-approval inspections, as well as routine compliance inspections. In 1987 he was promoted to the position of Regional Expert in the bioresearch monitoring area. However, he continued to do work in other areas as well, particularly with drugs & medical devices. Prior to his retirement from the FDA on April 1, 1994, he was involved in an investigation into data submitted to FDA in support of the NDA for Halcion. During this time, his work in the Medical Device area included participation in the silicone gel breast implant investigation and a Jan. 11, 1994 deposition in an injunction case, FDA vs. Laerdal Manufacturing Corp., regarding malfunction of automatic external defibrilators.

1963 – 1972: Investigator, U.S. Food and Drug Administration, Chicago District Office.

He performed a variety of FDA inspections, investigations, and other FDA work, including a detail doing import work, a detail as Chicago District Recall Coordinator, and a 90 day detail with the Bureau of Biologics, Bethesda, MD, involving the blood bank inspection program. While in Chicago, he was involved in the successful prosecution of a manufacturer of small volume injectables, and worked on a prosecution case involving a major manufacturer of LVP solutions. A sampling of other work includes inspection of a veterinary drug manufacturer that resulted in multiple seizures and product recall, and participation in the Krebiozen investigation, which involved the compiling of case histories of users of this alleged cancer cure, and which resulted in a jury trial of the manufacturers. He also conducted investigations involving Laetrile and other quack cancer drugs.

Military Service: 1963 – 1965: U.S, Army Biological Laboratories, Ft. Detrick, Frederick, MD.

Worked in the Virus and Rickettsia Division, performed virus purification and tissue culture work related to the biological warfare program.

EDUCATION:

• 1963 Bachelor of Science, Northland College, Ashland, WI

Wayne S.

Senior Compliance Consultant

AREAS OF EXPERTISE:

Wayne S. has more than 25 years of experience as a US Food & Drug Administration Chemist. He is currently assisting pharmaceutical manufacturers in gaining NDA and ANDA approval from the FDA, with the ability to market API and finished product pharmaceuticals in the United States. He is also conducting mock FDA Laboratory inspections in preparation for regulatory audits. He has successfully been able to do this through his experience in inspecting pharmaceutical manufacturers worldwide and working in and managing an FDA pharmaceutical testing laboratory.

EXPERIENCE SUMMARY:

The FDA Group, Worcester, MA

Provides professional cGMP FDA inspection preparation services to manufacturers of active pharmaceutical ingredients and finished product pharmaceuticals. Services provided include mock inspections, cGMP audits, assessment evaluations, and training. He has assisted in preparing pharmaceutical laboratories for ISO 17025 laboratory accreditation. He has expertise in writing laboratory operational and managerial SOPs and other work instructions. He also has experience in review of DMFs and the CMC portion of NDAs, ANDAs, and NADAs. In addition, he has experience in verifying the analytical methods submitted with NDAs, ANDAs, and NADAs for FDA approval.

US Food & Drug Administration Chemist (1980-2006).

- More than 30 FDA inspections of API and finished product pharmaceutical manufacturers in western, central and eastern Asia, Europe and the United States.

- Eighteen years experience as an analytical pharmaceutical chemist with a wide range of experience with various analytical techniques and equipment. Participated in numerous team drug inspections at local Philadelphia area pharmaceutical manufacturing firms and contract testing laboratories.

- Ten years experience in review of DMFs and CMC portion of NDAs and ANDAs submitted to FDA by regulated industry.

- Eight years experience in verifying the analytical methods submitted with NDAs and ANDAs for FDA approval as the NDA/ANDA Coordinator for the FDA Philadelphia District Laboratory. Coordinates with NDA and ANDA reviewers at the Center for Drug Evaluation and Research, Office of Generic Drugs and the Division of Field Science on what methods need to be verified by FDA. Coordinates with Industry Regulatory Affairs Directors about requests for samples, standards and specialized equipment needed to verify the methods. Reviews the analytical data obtained from each Method Verification and coordinates with FDA reviewers to determine the approval or disapproval status of the subject method based on laboratory findings.

- Four years experience as a member of FDA International Drug Inspection Cadre, participating in the laboratory portion of numerous team drug GMP and Pre-Approval inspections at API and finished dosage form manufactures and contract testing laboratories around the world.

- Two years experience as the Assistant Quality Manager for the FDA Philadelphia District Laboratory, with hands on formation of the laboratories Quality System in preparation for ISO 17025 accreditation.

- Positions held with FDA include:

• March to September 2006: Acting Laboratory Supervisor
• 2004 to 2006: Internal and National Proficiency Sample Monitor
• 2004 to 2006: Assistant Quality Manager
• 2003 to 2006: Member of FDA International Drug Inspection Cadre
• 1998 to 2006: NDA/ANDA Coordinator for FDA Philadelphia District Laboratory
• 1980 to 1998: Analytical Pharmaceutical Chemist.

EDUCATION AND TRAINING:

• B.A. degree from Rutgers University, Camden, NJ, 1968 with a major in Chemistry.
• US Navy Officer Candidate School, Newport, RI, 1971
• FDA Training received, related to laboratory procedures and inspections:

o Spectroscopy Instrumentation 12/04

o Record and Data Management : ISO 4.12 08/04

o A critical Review of Method Validation 06/04

o Quality Management Systems in the Laboratory 05/04

o Document Control 04/04

o Strategies for HPLC & GC Method Development 11/03

o Investigative Interviewing 11/02

o API Inspection Seminar 03/02

o ION Chromatography Seminar 12/01

o PAI – Industry Perspective 02/01

o FAME Leadership Skills Workshop 08/00

o USP Reference Standard Seminar 05/00

o Stability Inspection Seminar 04/00

o Quality Systems & Audit Course 03/99

o Advanced Chromatographic Techniques 09/97

o Inspection of Pharmaceutical Laboratories 09/96

o Mass Spectroscopy & Regulatory Applications 07/92

o Drug Forensics 07/89

• FDA Training given at various FDA functions

o Pre-Approval Inspection Requirements: Sample Collection at FDA PAI Training Course 04/04 and 08/04

o An FDA Field Lab Perspective on NDA/ANDA Method Validation at an FDA meeting of the Office of Generic Drug / CDER Review Chemists 07/02

o Laboratory Audits at FDA New Hire Training for Investigators 10/01

o Meeting System Suitability – Adjustments or Method Change at USP/FDA Open Forum in Philadelphia 12/99

FDA AWARDS, COMMENDATIONS, AND ACHIEVEMENTS:

• 2006 FDA Leveraging / Collaboration Award (National Group Award) for exceptional collaborative work by leveraging the support of Customs and Border Protection and Postal Service
• 2005 FDA Group recognition Award (National Award) for the development and implementation of the compounding pharmacy survey
• 2001 FDA Award of Merit (National Individual Award) for outstanding services to the Agency as Philadelphia District Laboratory’s NDA/ANDA Coordinator
• 1999 FDA Commendable Service Award (National Individual Award) for directly assisting the Agency to uncover a potentially serious health hazard in soft drink
• 1989 FDA Award of Merit (National Group Award) for outstanding efforts put forth by Philadelphia Laboratory personnel related to the Chilean Fruit Emergency
• Numerous Cash Awards for various outstanding work in the FDA Philadelphia District Laboratory
• Excellent or Outstanding Performance Ratings every year of employment with the FDA

Jack N.

Senior Compliance Consultant

AREAS OF EXPERTISE:

Jack N. has more than 37 years of experience as a US Food & Drug Administration Investigator. His FDA experience includes device manufacturing, repacking, and compliance. He has broad experience in blood banking, plasma operations, clinical investigators, food, dietary supplements, and cosmetic inspections. He specializes in Medical Device Quality System Inspections, Drug cGMP, and clinical investigator inspections.

EXPERIENCE SUMMARY:

The FDA Group

• Training of Quality Assurance and Quality Control Laboratory
  Personnel – GMP Training, FDA Inspectional Procedures
• Pre-approval Inspections, Due-diligence Audits, Validity Assessments (Data Integrity), Manufacturing Operations and Quality Control Laboratory Auditing
• Audits of Medical Device and In-vitro Diagnostic Manufacturing
  Facilities
• Simulated FDA Pre/post-approval Inspections
• cGMP Inspections and development of responses to FDA Notices of
  Observations and Warning Letters
• Medical device and pharmaceutical industries consultant
• Performed medical device QSR and ISO audits
• Conducted training / prepared pharmaceutical and medical device facilities for FDA inspections
• Served as Acting Director of Quality Assurance at a medical device firm; reviewed and approved corrective and preventive action reports, document control records, non-conformance reports, laboratory investigations, failure analysis reports, and customer complaints
• Conducted assessments of client studies, procedures and programs to determine compliance
• Assisted with development and implementation of quality systems for pharmaceutical and medical device companies to comply with QSR and ISO requirements
• Developed and implemented corrective action plans to address deficiencies
• Conducted GMP audits and mock FDA inspections

ASSOCIATE DIRECTOR OF QUALITY SYSTEMS – QUINTILES CONSULTING

• Medical device and pharmaceutical industries consultant
• Conducted assessments of client studies, procedures, and programs to determine compliance
• Assisted with development and implementation of quality systems
• Developed and implemented corrective action plans to address deficiencies
• Conducted GMP, GLP, and mock FDA inspection audits of laser, infant formula (thermally processed and aseptically filled) manufacturers, and glucose monitoring devices
• Worked at IVD manufacturer under Consent Decree; involved in Quality Systems development and product and process validations using a risk-based approach
• Conducted “FDA-interface” type training sessions
• Performed due diligence audits of contract manufacturing sites for coronary stents manufacturer; reviewed Quality Systems processes: product/process validation, vendor approval / qualification, design control, batch record review, and operating procedures

SENIOR INVESTIGATOR; DISTRICT AND REGIONAL HEALTH FRAUD COORDINATOR; INVESTIGATOR; RESIDENT-IN-CHARGE – US FDA

• Conducted regulatory investigations of medical devices, compressed medical gases, clinical research investigators, GLPs, institutional review boards, dietary supplement manufacturers, source plasma centers, cosmetic manufacturers, and food processors
• As member of Foreign Cadre, conducted international investigations of medical device manufacturers who produced endoscopes ultrasound machines, anesthesia trolleys, cochlear ear implants, pacemaker leads, spinal implants, syringes, blood collection sets, drug sets, dialysis filtration systems, and respiratory monitoring systems
• Conducted plant inspections, sample collections, and special investigations; areas of specialization included acidified and low acid food processing, drug repackaging, and veterinary drug manufacturing
• Prepared work plan and schedules of inspections of numerous FDA-regulated firms engaged in acidified and low acid food processing, medical devices, bulk pharmaceuticals, GLPs, clinical investigations, plasma collection, blood collection / processing, veterinary drugs, and fish processors.
• Conducted plant inspections, sample collections and special investigations including for acidified and low acid food processors, dairy processing plants, and fish processors

PRESENTATIONS:

• AVIRON APRIL, 2001

Logistics of an FDA inspection

• CLEAN ROOM EAST MARCH, 2002

FDA inspections made easy

• MDM EAST JUNE, 2004

QSR applied to product development

• MDM EAST MAY, 2001

FDA inspections made easy

• MDM MINNEAPOLIS AUGUST, 2002

QSR applied to product development

• DESIGN CONTROLS

RECOGNITION AND AWARDS:

• Numerous “Outstanding” Performance Ratings
• Commissioner’s Commendable Service Award for work performance and training employees
• Many “Group Performance Awards”
• Cash Awards for “Individual Accomplishments”

TRAINING AND EDUCATION:

• Basic Bacteriology Course
• Basic Drug Manufacturing Course
• Evidence Development Course
• Basic Food and Drug Law Course
• Low Acid and Acidified Foods Course
• Pharmacology and Experimental Therapeutic Course
• Basic Blood Banking Course
• Medical Device Basic Course
• Updated Food and Drug Law and Evidence Development Course
• The Reid Technique of Specialized Interviews Course
• Bachelor’s Degree in Fish & Wildlife Management Iowa State University Ames, IA

John F.

Senior Compliance Consultant

AREAS OF EXPERTISE:

John F. has more than 30 years experience in the Pharmaceutical and Pharmaceutical Packaging industries with extensive experience in the areas of Laboratory Management and Food and Drug Administration Regulations. His experience includes various technical management positions in Quality Control, Technical Service, and as a Director of Research and Development in Pharmaceutical Packaging.

Before starting his consulting career he spent 8 years with the Food and Drug Administration, the last 3 of which were as Director of the Science Branch of the Philadelphia District. This involved frequent interaction with FDA headquarters. The Laboratory’s responsibilities included evaluating the procedures of the Pharmaceutical firms in the states of Pennsylvania, Delaware, and New Jersey. Chemists from that Laboratory participated in inspections both in the United States and internationally.

He assists Pharmaceutical firms in Technical, Regulatory, and Management areas, all of which have the goal of getting clients’ products to the market in the least amount of time by avoiding regulatory and other delays.

John F. holds a B.A. in Chemistry from LaSalle College, an M.S. in Physical Chemistry from St. Joseph’s College, and an M.B.A. in Marketing and Finance from Temple University. From 1978 to 2000 he was an adjunct instructor at various Philadelphia area colleges, teaching Physical Chemistry, Finance, and Marketing. In recent years, he taught in the M.B.A. program at Pennsylvania State University and in Temple University School of Pharmacy’s Master of Science in Quality Assurance/Regulatory Affairs program, where he instructed professionals at the graduate level.

John F. instructs in subjects comprising “the business end of science” as detailed in his books The Executive MBA for Engineers and Scientists and Effective Financial Tools for Scientific Managers, published by CRC Press.

Director, Science Branch,

Philadelphia District FDA 1992-1996

Philadelphia District Science Branch includes all of Pennsylvania, New Jersey, and Delaware.

Directed, through intermediate managers, a laboratory staff of 30 persons whose activities involved methods verification of New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs), Drug Product Surveys, and Research Projects. Interfaced with my counterparts in the Investigation and Compliance branches, and with Headquarters in Rockville, Maryland.

- Improved Lab’s “Time Frame” percentage from 68% to 90%, a figure considered to be excellent. The Lab moved from 17th place out of 18 Labs up to 2nd place, in one year.

- Formed the first autonomous team, consisting of five analysts. This major structural change was very successful, and I instructed others at various FDA locations on the formation of self-directed teams. The team had a record of over 95% completion of projects within time frames.

- Formed the first “Experimental Pharmapartnership” with some Pharmaceutical firms and Philadelphia FDA to meet and discuss such items as:

• Validation required in computer systems.
• Validation of software updates.
• Feasibility of “Drug Master File” concept for source codes and other proprietary programs.

- Assigned Chemists to domestic and international investigations, coordinating and negotiating with Investigations Branch and Headquarters International Division.

- Directed the research projects conducted by the Laboratory.

- Interacted with foreign guests and dignitaries interested in comparing their own regulatory agencies to FDA. Have hosted the Commissioner’s counterparts from Kenya, Czech Republic, China, Armenia, and other countries.

Special Projects, Philadelphia FDA

Special Assignments from the Regional Director 1989-1992

• Conducted a management review of supervisory persons, which led to a major revision of assignments to streamline their work, primarily by eliminating redundancies.
• Assisted in the establishment of a forensic program for generic drugs to ensure regulatory compliance.
• Special projects relating to best management structure and assignments for the Region. Much of this involved delegating more decision making to lower levels.

J. Associates and J.F. Seminars 1982-1989

Drawing on my expertise in the areas of:

• FDA Regulations
• New Product Development
• Marketing Research and Marketing
• Financial Aspects of Product Development

Formed my own business. Served clients in the areas listed. Interfaced with FDA on such issues as: establishing Drug Master File (DMF), chemicals extracting from package into the medicinal preparation, validation procedures, etc. Prepared and delivered training seminars on Effective Communications, Negotiating Techniques, Business Aspects of the Technical Function, Strategic Planning, and delivered seminars for other seminar/training organizations.

The West Company

Assistant Director of Laboratories 1966-1982

Leading manufacturer of elastomeric pharmaceutical packaging components. Held positions of increasing responsibility from Supervising Chemist of Quality Control, to Manager of Technical Services, to Assistant Director of Laboratories in charge of Research & Development. Responsible for hiring personnel, establishing capital and operating budgets, conducting market research, and analysis of potential acquisitions.

• Planned and built a 4-group Research & Development department.
• Prepared the 5-year strategic plan for the company in 1980.
• Responsible for taking R & D projects through pilot plant to full scale-up in production, and coordinating with marketing function.
• Primary liaison with FDA and other agencies regarding regulatory situations.

Wyeth Laboratories 1964-1966

Senior Research Chemist. Designed analytical methods for new pharmaceutical raw materials and formulations.

SKF Industries 1961-1964

Research Chemist. Designed new methods and procedures for metals and lubricants.

Smith Kline & French Laboratories 1957-1961

Research Chemist. Designed analytical methods for new pharmaceutical raw materials and formulations.

EDUCATION:

B.A. Chemistry, La Salle College, Philadelphia, PA

M.S. Physical Chemistry, Saint Joseph’s College, Philadelphia, PA

M.B.A. Marketing and Finance, Temple University, Philadelphia, PA

ADDITIONAL:

Completed various high level courses such as:

• American Management Association’s Executive Effectiveness Course
• FDA Executive Management Course
• FDA Law and Evidence Development Course
• and several others

PUBLICATIONS:

“Moisture Vapor Transmission Measurement by Gas Chromatography.” Bulletin of The Parenteral Drug Association, July-August 1976.

“Applications of X-Ray Fluorescence Spectrometry to the Analysis of Pharmaceutical Packaging Materials.” Bulletin of The Parenteral Drug Association, November-December 1977.

“Joint Vendor/User Approach to Stopper Selection on medicinal products.” Journal of Parenteral Science and Technology, May-June 1985.

“You Know What You’re Telling Them … Do You Know What They’re Hearing (Seeing, Thinking)?” The Resource, American Society For Training And Development, June & July 1990.

“Recognizing Personality Differences in Communications.” The Resource, American Society For Training And Development, November & December 1990.

“How to Run an Effective Meeting.” The Resource, American Society For Training And Development, January 1992.

“Managing an Analytical Chemistry Laboratory.” Today’s Chemist at Work, August 1992.

“Say What You Mean.” Today’s Chemist at Work, August 1993.

“The Communications Paradox.” Resource, American Society For Agricultural Engineering, February 1996.

“Distributing Agricultural Chemicals: A new, environmentally friendly way to approach an old system.” Resource, American Society For Agricultural Engineering, April 1997.

“Taking the Mystique out of GLPs.” Journal of GMP Compliance, Volume 3, Number 1, October 1998.

“How to Avoid Certain Pitfalls in Pharmaceutical Package Product Compatibility—Some Things to Consider in Proper Rubber Stopper Selection.” Pharmaceutical Packaging and Manufacturing Sourcer, (PMPS), March 2000.

“Discovering the Cause of a Drug’s Defect.” Trial – Journal of the American Association for Justice, Volume 44, Number 11, November 2008, with co-authors Attorneys Eugene C. Brooks IV and James Everett Shipley of Brooks Law Firm.

POSTER PRESENTATIONS:

“An Innovative, Environmentally Friendly, Agricultural Chemical Delivery System.” Poster Presentation, American Society of Agricultural Engineers, Annual National Meeting, Chicago, Illinois, June 1995.

“Improved Dissolution Requirements for Griseofulvin Microcrystalline Capsules and Ultramicrocrystalline Tablets Based on Testing of Marketed Products.” Poster Presentation, American Association of Pharmaceutical Scientists, Annual National Meeting, Miami, Florida, November 1995. For the Food and Drug Administration, with co-authors, S. Nasir Ali, Larry A. Ouderkirk, and Vinod Shah.

Accepted in 1996 for the United States Pharmacopeia as the official method.

PATENTS:

“Chemical Dispensing Device and Method.” US patents 5,620,499, April 15, 1997, and 5,730,773, March 24, 1998. Issued to J.F.

BOOKS:

Effective Financial Tools for Scientific Managers, Lewis Publishers Inc., Division of CRC Press, Chelsea, Michigan, January 1994.

The Executive MBA for Engineers and Scientists, CRC Press, Division of Taylor & Francis Group, December 2009.

BACKGROUND FOR LITIGATION:

J.F.’s recent previous depositions were for:

1- The Miller Firm LLC in Orange, Virginia. Provided document review and deposition

regarding Actavis and their product Digitek in MDL 1968. Deposed in Savannah,

Georgia, June 2010.

2- Mainor Eglet Cottle LLP in Las Vegas, Nevada. Deposed in Las Vegas, February, 2010.

Henry Chanin, et al. v. Desert Shadow Endoscopy Center et al. Other defendants were Teva and Baxter pharmaceutical companies. Case number 08A571172. Clark County Courts. Eighth Circuit Court of Nevada.

3- Connelly Law in Tacoma, Washington. Deposed in Savannah, Georgia, April 2008. Angela Olson, Plaintiff, vs Septodont, Inc., Burkhart Dental, Inc., Reeve Burkhart Dental Supply Company, Burkhart Dental Supply Company, and John Does 1-5. In The Superior Court of the State of Washington No. 06-2-10742-5 for Pierce County.

He has provided Subject Matter Expert reports in all of the above, and more.

J.F. has reviewed patents in patent infringement cases.

He has two patents himself and as such, is familiar with the content of patents.

Teaching Experience as Adjunct Professor

John F.

A Sample of Industry/Government Training Seminars

Composed and Presented by

J.F.

Chris R.

Compliance Consultant

AREAS OF EXPERTISE:

Chris R. has more than 5 years of experience as a US Food & Drug Administration Investigator. His FDA experience includes pharmaceutical manufacturing, repacking, and compliance. He has broad experience in drug, medical device, clinical investigators, food, dietary supplements, and cosmetic inspections. He specializes in Drug and Device cGMP, 510k/NDA/ANDA/DMF, and clinical investigator inspections.

EXPERIENCE SUMMARY:

The FDA Group, Worcester, MA

- Comprehensive cGMP Inspections and QA Evaluations: includes on-site inspections of manufacturing facilities for compliance with cGMP regulations and/or Application commitments.

- Comprehensive Quality Assurance Program Evaluations: evaluation of Quality Systems controlling manufacturing and identification of compliance problems. Formal assistance in developing procedures, validation plans, corrective actions, etc. to meet cGMP requirements.

- NDA/ANDA Pre-Approval Inspections, Audits, and Readiness Assessments: includes assessments at every stage of development, including early development (Phase I, etc.) to time of NDA/ANDA/DMF filing to identify potential problems as companies head toward a Pre-Approval Inspection and Regulatory Submissions.

- cGMP and Pre-Approval Training: insight into FDA’s expectations regarding a number of issues including development, manufacture of clinical materials, Pre-Approval inspections, laboratory and manufacturing operation, scale-up, validation, and post-approval cGMPs.

- Vendor Assessments and cGMP Audits: assistance in identifying suitable vendors that are in compliance with cGMPs and avoiding the costly mistakes of using non-compliant sources.

- Liaison and Coordination Activities with FDA Field and Headquarters Offices: includes written correspondence or personal meetings.

Olympus America, Inc. – Project Manager

Served as a Project Manager for a $1.6 million dollar Clinical Trial Project to support two (2) FDA cleared devices, including clinical trail monitoring, FDA submission and follow-up correspondence. Author and contributing member of a 510(k) submission team for three (3) FDA cleared products Provided training on FDA related topics to colleagues and outside medical personnel

Developed and maintained adequate and accurate supplier audit files by performing on-site audits and follow-up correspondence. Harmonized the primary QSR processes between the Life Science Business Groups including training, complaint handling and Non-Conforming Products.

US Food & Drug Administration – Investigator

Served as the primary Investigator for over fifty (50) Domestic and Foreign Inspections, including sterile, injectable pharmaceuticals, Class II and III devices (sterile and implantable) and Phase II and III BIMO inspections of Pharmaceutical, Medical Device and Biomedical Research Organizations. Collected and documented scientific and quality related issues used to obtain compliance through warning letters, seizures and product detentions in observance with the Mission Statement.

PRESENTATIONS:

• In-house training, “Change Control Process & How it affects a PMA Product”, July 2008, Ennis, Ireland
• European Field Evaluators Meeting, “Alphafetoprotein Clinical Results and Lessons Learned”, October 2008, Munich, Germany
• SMU Dedman School of Law, “FDA Experiences from a former Investigator”, April 2009, Dallas, TX

RECOGNITION AND AWARDS:

• U.S. Food and Drug Administration Group Recognition Award, May 2004
• U.S. Food and Drug Administration Leveraging/Collaboration Award, May 2004
• U.S. Food and Drug Administration Outstanding Service Award, May 2006

• Member of the International Inspection Cadre and conducted six (6) GCP clinical audits in Turkey and Bulgaria, January – February 2007 and Germany, May 2007
• Chosen as the Recall and Emergency Coordinator for the Dallas District Office for three (3) months
• Numerous cash awards

TRAINING AND EDUCATION:

• Basic Biomedical Research Course, St. Petersburg, FL, January 2003
• Basic Food and Drug Law & Evidence Course, Nashville, TN, March 2003
• Advanced Biomedical Research Course, Rockville, MD, March 2004
• Basic Medical Device Course, Denver, CO, August 2004
• Basic Drug GMP Course, Indianapolis, IN, December 2005
• Active Pharmaceutical Ingredients Course, Iselin, NJ, February 2006
• Pre-Approval Inspections, Rockville, MD, May 2006,
• Process Validation Course, Rockville, MD, June 2006
• Process Validation of Automated Systems, Rockville, MD, September 2006
• RAPS Annual Meetings – 2007, 2008
• Bachelor’s Degree in Zoology, Texas A&M University, College Station, TX, 2001
• Masters in Business Administration, University of North Texas, Denton, TX (projected 2010 graduation)

Tim A.

Senior Compliance Consultant

AREAS OF EXPERTISE:

Tim A.’s career spans 28 years in the pharmaceutical/consumer products industries. He brings diversified academic and scientific credentials: 8 years in formulary and analytical R&D, 8 years in pharmaceutical Quality Control/Quality Assurance/cGMP compliance, and 18+ years in pharmaceutical Regulatory Affairs, the latter which embodies tenure at FDA as a Review Chemist.

As a retained consultant, clients are furnished services in the areas of global regulatory filing review, writing, Agency negotiation, strategic advisories, contracted management services, and executive search.

Filing services include review/writing of Chemistry and Manufacturing Controls (CMC) sections for NDA, ANDA, IND (biologicals and new chemical entities), 505(b)(2), DMF, 510(k), Type I & II, MAAs/CTX and International filings. Other services include cGMP (QC/QA), due-diligence, mock pre-approval inspections, R&D portfolio, and Business Analysis.

EXPERIENCE SUMMARY:

Consultative projects have included the following:

• Sr. CMC Consultant and Subject Matter Expert (SME) MEDTRONIC AVE; Endeavor® Zotarolimus drug eluting stent, IDE, CTA, and PMA filings. PMA approved 2008.
• Sr. RA-CMC Project Management Consultant ALLERGAN; redesign of Change Control systems, RA-Mfg- Quality Change Control Review board; RA management succession plan, department work-flow re-structuring.
• Sr. Quality Systems Consultant, MEMORIAL SLOAN-KETTERING CANCER CENTER. Establishment of a regulatory & cGMP compliant quality system for 11 Clinical Investigator’s laboratories and API synthesis labs. IND preparation and review (biologics, radio-labeled peptides, devices, and new chemical entities), SOP composition, and crafting of a management structure to administer Regulatory/Quality functions.
• Sr. Bio-analytical SME, MDS-PHARMA; 5-year retrospective bioequivalence review mandated by FDA.
• Sr. CMC SME, US PHARMACOPOEIA; USAID/WHO-funded Promoting the Quality of Medicines Program
• Sr. CMC SME, BOEHRINGER INGELHEIM; site-change, and co-formulation sNDA’s for Micardis®-HCT
• Sr. CMC SME, BMS; Compliance Submissions Initiative; European (EU) filings, eCTD Type I and II variations.
• Sr. CMC SME, GENZYME; preparation of supplemental European (EU) eCTD filings, supporting manufacturing changes, based upon approved US submissions for Renvela®. Change control management.
• Sr. CMC SME, MILLENNIUM (TAKEDA); strategy and prep of US filing for acquired EU-marketed product.
• Sr. CMC SME, AJANTA; review advisory for first India-originated ANDA filings, advising first WHO certifications.
• Sr. CMC SME, JANSSEN (J&J); Drug Master File (DMF) Annual Reporting and amendment filing preparations.
• Sr. CMC Due-diligence Consultant, SCIELE (SHIONOGI); tech acquisition R&D assessment, vendor certs.
• Sr. CMC Pharma Development Plan Consultant, CARBYLAN; venture-backed start-up; sterile drug-device.
• Sr. R&D Portfolio Analysis Consultant, PHARMACIA; Assessment of projected portfolio sales revenues, launch dates, phase, probability of success, costs: proof of concept, R&D, promotion — in context of NPV.
• Sr. cGMP Compliance Consultant to WYETH (2000), and GSK Consent Decree remediation (2006).

Contracted and interim-regulatory and quality management services have included the following:

• As Vice-President of Regulatory Affairs and Quality Operations for the “virtual” development-stage pain management firm, AlgoRx, Inc. (now, Anesiva), CMC, Formulation, QA/QC, and Regulatory filing management is furnished to out-sourced domestic and international development units for three products, Phases 1, 2 and 3:

• Synthetic new chemical entity (NCE); pre-formulation studies — proof of concept, and first in man trials.
• Adlea^TM parenterally administered formulations of ultra-purified, and synthetic Capsaicin (now in Phase 3).
• Zingo^TM (PowderJectâ lidocaine) needle-free anesthetic. Drug-device 505(b)(2) NDA approved, 2007.
• INDs, CTXs, staffing; external vendor selection, and cGMP compliance oversight, batch record review; international/domestic clinical study supplies management; regulatory strategy and Agency meetings.

• As acting Vice-President, Regulatory Affairs, Taro Pharmaceuticals, USA, Inc US, Israel, Canada regulatory functions were coordinated, toward submission of US, Canadian, and International filings. Approvals obtained for 19 ANDAs, and 2- 510(k)s, 10 original DMFs, and an MAA for UK. Primary liaison for negotiations with Office-level regulatory bodies on bioequivalence, CMC, and Application deficiency resolution. Accomplished senior level (i.e., Director and VP) staffing of regulatory departments for Taro in Canada and NY.

Pre-IND meetings and PAIs. Authored strategic plans for accomplishment of timely submission

Regulatory filings. Authored product- specific ANDA Preparation Guidelines and a universally

applicable Drug Master File Preparation Guideline. Amendments, supplements, annual reports.

International Rx and OTC approvals

• As acting Director, QA/Regulatory GMP/GLP, Oread, Inc. (acquired by Emisphere Technologies, 2000), starting-up Oread’s Rapid Response Laboratory, including SOP review/revision/composition, senior staff sourcing, establishment of laboratory GLP/GMP compliance systems, client support, regulatory liaison/advisory.

Partnering with and acquisition (1998) of Clinton Research Consultants, Easton, CT

Critical analysis of new product proposals for scientific feasibility and domestic/international marketability, profiling novel formulary and therapeutic preparations. Evaluation of marketing plans and new product proposals for anti-viral, anti-thrombotic, polypeptide, enzymatic, new chemical entities, biotechnology products, and unique formulation systems as well as authored and promoted novel contraceptive, glucose metabolism, and palatable cold symptom relief therapies.

1994-1996 SANDOZ PHARMACEUTICALS CORPORATION East Hanover, NJ

Creighton Pharmaceuticals Corporation division

Senior Associate Director, and division Vice-President, Drug Registration and Regulatory Affairs

Successfully guided, educated, and project managed the domestic and international regulatory and manufacturing functions within Sandoz, toward preparation and timely submission of Abbreviated New Drug Applications (ANDAs) and Drug Master Files (DMFs) to the FDA for Sandoz products, which have and/or are due to come off-patent.

Set the standard for review of competing generic filings through preparation of five first-of-their-kind original ANDAs for Clozapine, Cyclosporine, and Bromocriptine dosage forms, as part of a larger strategy to promote Sandoz brand protection.

Filed landmark citizen’s petition in conjunction with preparation of first-of-their-kind patient-based clinical bioequivalence studies (Clozapine) to set the industry standard for review by the Agency; similar legal and strategic advisories rendered for the other flagship products. Coordinated the activities of outside consultants.

Regulatory advisories in the areas of cGMP compliance, Chemistry and Manufacturing Control documentation and bioequivalency standards, from first-hand knowledge of FDA/OGD expectations. Business development and licensing advisories provided in the context of OTC switches, joint ventures, site changes, and new products. Promotion from Associate Director to Senior Associate Director for Drug Registration and Regulatory Affairs (DRRA) for Sandoz and awarding of the title of Vice-President of DRRA for the Creighton Pharmaceuticals generics division.

1992-1994 UNITED STATES FOOD AND DRUG ADMINISTRATION Rockville, MD

Review Chemist (ranking), Branch 4, Division 1, Office of Generic Drugs, Centers for Drug Evaluation and Research

Employed superior communication skills in drafting coherent deficiency or approval letters in the course of thorough review of chemistry and manufacturing controls sections of original and supplemental ANDAs and DMFs, resulting in fewer required review cycles for applicants. Sought and obtained expanded assignments at other FDA offices within the Centers for Drug Evaluation and Research (CDER), reviewing INDs and supplemental NDAs. Delegated with branch supervisory duties in the absence of the branch chief. Contributions to several policy-crafting CDER committees: Chemistry and Manufacturing Controls Coordinating Committees (CMCCC), prepared policy and procedure guides (PPGs) for bioequivalence evaluation of topicals.

Contributions to drug monographs performed in conjunction with preparation of FDA guidances for presentation to the International Conference on Harmonization (ICH).

Appointed to position of Program Manager for the industry visitation initiative. Serving on the Committee for Continuing Training and Educational Development, headed up favorably received visitations to 16 sites planned and scheduled on behalf of 40 OGD review staff to broaden reviewers’ technological exposure and to promote industry-Agency dialog. Program slated to expand to include other CDER offices.

1987-1992 BAYER, USA, Miles, Inc., Pharmaceuticals division West Haven, CT

Associate Scientist (ranking)

Group leadership responsibilities, including the training and coordination of the assigned workloads of 8 technicians for the finished product and raw materials Quality Assurance laboratory. Recommendations implemented for equipment upgrades; delegated with laboratory supervision in the absence of managers. Increased group productivity, efficiency, and time savings by training staff in instrumentation troubleshooting techniques and maintenance toward safe and effective operation of standard equipment and automated control devices (HP-3350A).

Sharpening existing and new methods for clarity and editing / validation of analytical methods for NDA and IND submissions accomplished, conforming European (Bayer AG) methods to USP protocols.

Scheduling of analytical testing for parenterals, cremes, ointments, lotions, otic solutions, tableted products, and raw materials and timely coordination with manufacturing toward negotiated product and packaging release timetables.

1984-1987 PURDUE-FREDERICK RESEARCH CENTER Yonkers, NY

Scientist, Experimental Formulations

Development of stability protocols and bioassay methods and validations, employed to determine drug and metabolite levels in plasma and serum in pre-clinical animal and clinical patient studies for newly developed drug formulae (Phases I and II). Preparation and group presentations of technical reports, detailing data, which linked chemistries to critical pharmacokinetic studies; editing of test methods of European subsidiaries to conform to USP protocols. Participation in DEA and FDA audits.

Acquired comprehensive credentials in industrial pharmacy: Tableting and granulating techniques (experimental and clinical sustained release narcotic, antibiotic, and vasodilator formulations), film coating, freeze drying, Accelocoata fluid bed drying, and Glatt mixing equipment.

1982-1984 CLINTON RESEARCH CONSULTANTS, INC. Easton, CT

Contracted consumer products, applications research, and development services

NABISCO BRANDS, INC., Technology Center Wilton, CT

Research Technologist, product development, surfactant, pilot plant, and sensory studies.

THE FOXBORO COMPANY, Analytical Instrumentation Norwalk, CT

Applications Scientist, IR spectral software programming for a new product launch, the MIRAN 1-B.

SHAW MUDGE AND COMPANY, Fragrance Formulators Stamford, CT

Formulations Chemist, fragrance product development, QA, and rabbit conjunctival irritation studies

PATENTS AWARDED AND PROVISIONAL PATENTS PENDING (Co-inventor):

Synthesis and Purification of Capsaicin (Serial No. 10/821,473), April 8, 2004

Synthesis and Purification of Capsaicin (Serial No. PCT/US04/10745) April 8, 2004

Preparation and Purification of Synthetic Capsaicin (European patent application 04749854.8-2117-US2004010745)

Capsaicinoid Gel Formulation and Uses Thereof (Serial No. 60/630,577) November 24, 2004

Capsaicinoid Gel Formulation and Uses Thereof (Serial No. 11/286,059, docket No. 900.1034US) November 23, 2005

EDUCATION

MASTER OF INTERNATIONAL BUSINESS ADMINISTRATION

UNIVERSITY OF BRIDGEPORT

Bridgeport, CT

5/92 GPA: 3.6/4.0

Thesis: “ECONOMIC NEW WORLD ORDER, Global models structured after those of the EC toward continued international economic integration: the Commonwealth approach for the emancipation of command economies and the historical and geographical bases for regional free trading zones in the furtherance of competitive interdependence.”

MASTER OF SCIENCE, BIOCHEMISTRY

NEW YORK MEDICAL COLLEGE

Valhalla, NY

5/88 GPA: 3.4/4.0

5/88 GPA: 3.4/4.0

Thesis: “Synergistic reduction in proliferation of the histiocytic lymphoma cell line, U-937, by the combined action of recombinant interferon beta-ser and retinoic acid, and the associated changes in 2′-5′ oligoadenylate synthetase and ribonuclease L activities.”

BACHELOR OF SCIENCE, CHEMISTRY

VIRGINIA COMMONWEALTH UNIVERSITY Richmond, VA

5/82

BACHELOR OF SCIENCE, BIOLOGY

VIRGINIA COMMONWEALTH UNIVERSITY Richmond, VA

12/80

CONTINUING EDUCATION IN BUSINESS

LEADERSHIP-4 PERFORMANCE MANAGEMENT: Charter Oak Consulting Group

COMMUNICATION AND TEAM BUILDING: Gatto Training Associates

POSITIVE POWER AND INFLUENCE: Situation Management Systems

CONTINUING EDUCATION IN SCIENCES AND REGULATORY AFFAIRS

BIOEQUIVALENCE, BIOAVAILABILITY, AND THERAPEUTIC SUBSTITUTION: Technomic Publishing

BIOTECHNOLOGY: Centers for Drug Evaluation and Research Staff College

ISO 9000/Q90 DOCUMENTATION STANDARDS: Quality Alert Institute

EDUCATIONAL DEVELOPMENT MODULES IN PHARMACEUTICS: University of Maryland

Capsule Formulation, Filling and Manufacture; Dissolution and Bioavailability; Metered Dosage Inhalers; Creams, Ointments, and Lotions Formulation; Sustained Release Formulation; Parenterals; Packaging.

PUBLICATION:

“A flow injection analysis/mass spectrometry method for the quantification of polyethylene glycol 300 in drug formulations,” Zhang, J., Lin, J., Anderson, T.A., International Journal of Pharmaceutics, 282(1), pages 183-187 (2004)

MEMBERSHIPS

Food and Drug Administration Alumni Association

Regulatory Affairs Professional Society

American Association of Pharmaceutical Scientists

American Chemical Society

James F.

Senior Compliance Consultant

AREAS OF EXPERTISE:

James J. Farley has more than 30 years experience in the Pharmaceutical and Pharmaceutical Packaging industries with extensive experience in the areas of Laboratory Management and Food and Drug Administration Regulations. His experience includes various technical management positions in Quality Control, Technical Service, and as a Director of Research and Development in Pharmaceutical Packaging.

Before starting his consulting career he spent 8 years with the Food and Drug Administration, the last 3 of which were as Director of the Science Branch of the Philadelphia District. This involved frequent interaction with FDA headquarters. The Laboratory’s responsibilities included evaluating the procedures of the Pharmaceutical firms in the states of Pennsylvania, Delaware, and New Jersey. Chemists from that Laboratory participated in inspections both in the United States and internationally.

He assists Pharmaceutical firms in Technical, Regulatory, and Management areas, all of which have the goal of getting clients’ products to the market in the least amount of time by avoiding regulatory and other delays.

Jim holds a B.A. in Chemistry from LaSalle College, an M.S. in Physical Chemistry from St. Joseph’s College, and an M.B.A. in Marketing and Finance from Temple University. From 1978 to 2000 he was an adjunct instructor at various Philadelphia area colleges, teaching Physical Chemistry, Finance, and Marketing. In recent years, he taught in the M.B.A. program at Pennsylvania State University and in Temple University School of Pharmacy’s Master of Science in Quality Assurance/Regulatory Affairs program, where he instructed professionals at the graduate level.

Jim instructs in subjects comprising “the business end of science” as detailed in his books The Executive MBA for Engineers and Scientists and Effective Financial Tools for Scientific Managers, published by CRC Press.

Director, Science Branch,

Philadelphia District FDA                                        1992-1996

Philadelphia District Science Branch includes all of Pennsylvania, New Jersey, and Delaware.

Directed, through intermediate managers, a laboratory staff of  30 persons whose activities involved methods verification of New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs), Drug Product Surveys, and Research Projects. Interfaced with my counterparts in the Investigation and Compliance branches, and with Headquarters in Rockville, Maryland.

• Improved Lab’s “Time Frame” percentage from 68% to 90%, a figure considered to be excellent. The Lab moved from 17th place out of 18 Labs up to 2nd place, in one year.

• Formed the first autonomous team, consisting of five analysts. This major structural change was very successful, and I instructed others at various FDA locations on the formation of self-directed teams. The team had a record of over 95% completion of projects within time frames.

• Formed the first “Experimental Pharmapartnership” with some Pharmaceutical firms and Philadelphia FDA to meet and discuss such items as:
  • Validation required in computer systems.
  • Validation of software updates.
  • Feasibility of “Drug Master File” concept for source codes and other proprietary programs.

• Assigned Chemists to domestic and international investigations, coordinating and negotiating with Investigations Branch and Headquarters International Division.

• Directed the research projects conducted by the Laboratory.

• Interacted with foreign guests and dignitaries interested in comparing their own regulatory agencies to FDA. Have hosted the Commissioner’s counterparts from Kenya, Czech Republic, China, Armenia, and other countries.

 Special Projects, Philadelphia FDA

Special Assignments from the Regional Director   1989-1992

• Conducted a management review of supervisory persons, which led to a major revision of assignments to streamline their work, primarily by eliminating redundancies.

• Assisted in the establishment of a forensic program for generic drugs to ensure regulatory compliance.

• Special projects relating to best management structure and assignments for the Region. Much of this involved delegating more decision making to lower levels.

Jay Associates and James Farley Seminars                        1982-1989

Drawing on my expertise in the areas of:

• FDA Regulations
• New Product Development
• Marketing Research and Marketing
• Financial Aspects of Product Development

Formed my own business. Served clients in the areas listed. Interfaced with FDA on such issues as: establishing Drug Master File (DMF), chemicals extracting from package into the medicinal preparation, validation procedures, etc. Prepared and delivered training seminars on Effective Communications, Negotiating Techniques, Business Aspects of the Technical Function, Strategic Planning, and delivered seminars for other seminar/training organizations.

The West Company

Assistant Director of Laboratories                          1966-1982

Leading manufacturer of elastomeric pharmaceutical packaging components. Held positions of increasing responsibility from Supervising Chemist of Quality Control, to Manager of Technical Services, to Assistant Director of Laboratories in charge of Research & Development. Responsible for hiring personnel, establishing capital and operating budgets, conducting market research, and analysis of potential acquisitions.

• Planned and built a 4-group Research & Development department.
• Prepared the 5-year strategic plan for the company in 1980.
• Responsible for taking R & D projects through pilot plant to full scale-up in production, and coordinating with marketing function.
• Primary liaison with FDA and other agencies regarding regulatory situations.

Wyeth Laboratories                                                  1964-1966

Senior Research Chemist. Designed analytical methods for new pharmaceutical raw materials and formulations.

SKF Industries                                                          1961-1964

Research Chemist. Designed new methods and procedures for metals and lubricants.

Smith Kline & French Laboratories                                   1957-1961

Research Chemist. Designed analytical methods for new pharmaceutical raw materials and formulations.

EDUCATION

B.A. Chemistry, La Salle College, Philadelphia, PA

M.S. Physical Chemistry, Saint Joseph’s College, Philadelphia, PA

M.B.A. Marketing and Finance, Temple University, Philadelphia, PA

ADDITIONAL

Completed various high level courses such as:

•  American Management Association’s Executive Effectiveness Course
•  FDA Executive Management Course
•  FDA Law and Evidence Development Course
•  and several others

PUBLICATIONS:

“Moisture Vapor Transmission Measurement by Gas Chromatography.” Bulletin of The Parenteral Drug Association, July-August 1976.

“Applications of X-Ray Fluorescence Spectrometry to the Analysis of Pharmaceutical Packaging Materials.” Bulletin of The Parenteral Drug Association, November-December 1977.

“Joint Vendor/User Approach to Stopper Selection on medicinal products.” Journal of Parenteral Science and Technology, May-June 1985.

“You Know What You’re Telling Them … Do You Know What They’re Hearing (Seeing, Thinking)?” The Resource, American Society For Training And Development, June & July 1990.

“Recognizing Personality Differences in Communications.” The Resource, American Society For Training And Development, November & December 1990.

“How to Run an Effective Meeting.” The Resource, American Society For Training And Development, January 1992.

“Managing an Analytical Chemistry Laboratory.” Today’s Chemist at Work, August 1992.

“Say What You Mean.” Today’s Chemist at Work, August 1993.

“The Communications Paradox.” Resource, American Society For Agricultural Engineering, February 1996.

“Distributing Agricultural Chemicals: A new, environmentally friendly way to approach an old system.” Resource, American Society For Agricultural Engineering, April 1997.

“Taking the Mystique out of GLPs.” Journal of GMP Compliance, Volume 3, Number 1, October 1998.

“How to Avoid Certain Pitfalls in Pharmaceutical Package Product Compatibility—Some Things to Consider in Proper Rubber Stopper Selection.” Pharmaceutical Packaging and Manufacturing Sourcer, (PMPS), March 2000.

“Discovering the Cause of a Drug’s Defect.” Trial – Journal of the American Association for Justice, Volume 44, Number 11, November 2008, with co-authors Attorneys Eugene C. Brooks IV and James Everett Shipley of Brooks Law Firm.

POSTER PRESENTATIONS:

“An Innovative, Environmentally Friendly, Agricultural Chemical Delivery System.” Poster Presentation, American Society of Agricultural Engineers, Annual National Meeting, Chicago, Illinois, June 1995.

“Improved Dissolution Requirements for Griseofulvin Microcrystalline Capsules and Ultramicrocrystalline Tablets Based on Testing of Marketed Products.” Poster Presentation, American Association of Pharmaceutical Scientists, Annual National Meeting, Miami, Florida, November 1995. For the Food and Drug Administration, with co-authors, S. Nasir Ali, Larry A. Ouderkirk, and Vinod Shah.

Accepted in 1996 for the United States Pharmacopeia as the official method.

PATENTS:

“Chemical Dispensing Device and Method.” US patents 5,620,499, April 15, 1997, and 5,730,773, March 24, 1998. Issued to James J. Farley.

BOOKS:

Effective Financial Tools for Scientific Managers, Lewis Publishers Inc., Division of CRC Press, Chelsea, Michigan, January 1994.

The Executive MBA for Engineers and Scientists, CRC Press, Division of Taylor & Francis Group, December 2009.

The Placebo Effect: Counterfeit Drugs – A Crime Novel, Western Star Publishing, January 2012

BACKGROUND FOR LITIGATION:

James Farley’s recent previous depositions were for:

1- Purvis Gray, LLP, in Boulder, Colorado  80303

Deposed in Savannah, Georgia, November, 2011

Civil Action No. 10-CV-02291-RPM-CBS

Leslie G Berkowitz and Kathleen F Berkowitz v. MetWest dba Quest Diagnostics, Siemens

2 – Motley Rice Law Firm in Mount Pleasant, South Carolina.

Deposed in Savannah, Georgia, January, 2011. Digitek Products  Product Liability Litigation. MDL 1968. Defendant was Actavis.

3- The Miller Firm LLC in Orange, Virginia. Provided document review and deposition

regarding Actavis and their product Digitek in MDL 1968. Deposed in Savannah,

Georgia, June 2010.

4- Mainor Eglet Cottle LLP in Las Vegas, Nevada. Deposed in Las Vegas, February, 2010.

Henry Chanin, et al. v. Desert Shadow Endoscopy Center et al. Other defendants were Teva and Baxter pharmaceutical companies. Case number 08A571172. Clark County Courts. Eighth Circuit Court of Nevada.

5- Connelly Law in Tacoma, Washington. Deposed in Savannah, Georgia, April 2008. Angela Olson, Plaintiff, vs Septodont, Inc., Burkhart Dental, Inc., Reeve Burkhart Dental Supply Company, Burkhart Dental Supply Company, and John Does 1-5. In The Superior Court of the State of Washington No. 06-2-10742-5 for Pierce County.

James has provided Subject Matter Expert reports in all of the above, and more.

James has reviewed patents in patent infringement cases.

James has two patents himself and as such, is familiar with the content of patents.

Teaching Experience as Adjunct Professor

James J. Farley

A Sample of Industry/Government Training Seminars

Composed and Presented by

James J. Farley

Dennis M.

Senior Compliance Consultant

AREAS OF EXPERTISE:

 EDUCATION AND TRAINING

• San Jose State University. Bachelor of Arts, Biological Sciences,1976

• AAMI certified to Quality System Regulation compliance practices/passed AAMI proctored QS Reg. exam associated with course
• AAMI trained in Design Control Concepts
• AAMI trained in Process Validation Concepts
• AAMI trained in Part 11 and Software Auditing
• Graduate of FDA’s Basic Medical Device Investigation Course
• QSIT Certified by FDA (proctored exam)
• ISO 13485:2003 auditor course graduate/passed proctored RAB 13485:2003 certification exam
• Twenty one years drug compliance experience

RECENT TRIUMPHS

• Client firm is inspected by FDA after Mr. Moore’s consultation services, and fully passed the FDA audit, with no significant adverse findings. A full Quality System was created for this class II medical device manufacturer client.
• Client Traditional 510(k) cleared in 40 days. Cleared in 2011

• Client firm (three billion dollar plus device corporation) is assisted in creating an entirely new CAPA system in 2008. FDA inspects the firm in 2008, with no CAPA findings
• Client firm receives IEC 60601-1 and IEC 60601-1-2 certification
• Assisted a Finland device firm, on-site, to convince FDA to release an import detention
• Client firm successfully integrating web based sales of Rx class II medical device
• Created a CMS {Medicare /State of CA Rx-HMDR} quality system for a client
• Client firm 510(k) technical file created from 510(k) submission data. TF approved, CE Mark issued Mar 2008
• Client firm, using Mr. Moore’s consultation services to correct warning letter conditions, passes state of California license inspection.
• Created six system drug firm quality system
• On staff for www.complianceonline.com, providing webinars on medical device and pharmaceutical compliance subjects

EXPERIENCE AS A TRAINER

• On staff for AAMI, providing training services, on AAMI staff to give QS Regulation training
• On staff for Barnett, providing training services regarding QSIT,
• On staff for ComplianceOnline providing training in multivarious Gxp areas

PROFESSIONAL EXPERIENCE IN QA/RA

• October 2004-Present – Consultant offering global services for:

-          training for Quality System Regulation, design control, process design, compliance achievement

-          project planning assistance for drug plant start ups

-          510(k) submissions

-          IVD compliance

-          software compliance

-          risk management

-          MDD compliance

-          mock GMP/ISO audits

-          preparation of Technical File for product CE Mark submission/registration

-          equipment validation IQ/OQ/PQ

-          sterilization validation

-          HMDR quality system documents and personnel training

-          assistance during FDA and state drug and device government audits

• Aug., 1995  – October 2004 – SENIOR FOOD and DRUG INVESTIGATOR

• Nov., 1984 – Aug., 1995 – FOOD and DRUG INVESTIGATOR, Responsibilities and Achievements in prior position:

-          Experience with Cardiology Devices, including stent development,

graft placement devices, beating heart bypass development. Responsible

for approving licensure for Cardiology devices.

-          Responsible for design control compliance evaluation for Cardiology Devices, including stent development, graft placement devices, beating heart bypass development.

-          Responsible for evaluation of clinical data, including cardiology device patient data.

-          Medical device Quality System Regulation inspection, including regulatory decisions; am a fully credentialed FDA Quality System Regulation Medical Device Investigator

-          Quality System Regulation education for medical device manufacturers, including design Control education and auditing of medical device manufacturers. Presentation of training, and preparation of training materials.

-          Evaluation of complaints and MDR issues, regarding medical devices

-          Responsible for implementing interactions between Governmental agencies

-          Experience auditing for compliance radiation therapy planning systems, and mammography systems

-          Required to administer projects, from idea generation to completion, including warning letters and other regulatory functions

-          Involved with current State of California Third Party 510(k)

qualified body project

Jackelyn R.

Senior Compliance Consultant

AREAS OF EXPERTISE:

Jackelyn R. has over 28 years’ experience in all facets of Quality Assurance and Regulatory Compliance and is currently the President of Monarch Quality Systems Solutions, a consulting firm in New Jersey.  Ms. Rodriquez specializes in U.S. Regulations and International, which define Quality Systems and Systems-based Implementation & Auditing (FDA’s QSR/GMPs) 21 CFR Parts 210 & 211, 600, Part 820 and Part 11, ISO 9001/2000, 13485/2003, MDD/IMDD requirements, Canadian Regulation requirements for Medical Device, Pharmaceutical and Biologics Industry, Investigations and CAPA, Process Validation, Document Control, Supplier Quality Assurance systems implementation, Quality Engineering, Risk Management/hazard analysis..  As a result, have created and implemented entire Quality Systems for several Pharmaceutical, Biologics and Device companies. Jackelyn R. also has extensive knowledge of Compliance- Inspections, Facilitating responses to address FDA-483s and Warning Letters, Electronic Records/Electronic Signatures and Documentation Systems, as well as HIPAA requirements, as well as Lean Manufacturing and Six-sigma.

Jackelyn R. has performed internal clinical audits of ongoing clinical trials in progress across the organization (for both US and EU trials).  As well as, completed an objective assessment of where the client’s clinical trials documentation was in with respect to processes and systems and compliance to both US FDA and EMEA, ISO14155 (2011) requirements in order to provide and address any gaps, and remediation task in order to address 483 and warning letters.

The main intent of the audit and assessment activities was to identify ways that the customer could improve their processes and systems and better prepare as an organization for the challenges ahead.

Action Plan for Clinical Study Quality Control Review included an internal audit on all active clinical trials. The scope: adherence to SOP’s and adherence to US and EMEA regulatory guidelines.

Her wide-ranged experience and recognized expertise in these areas have acquired her guest speaker positions worldwide, which include several FDA validation workshops.  She has worked closely with CDRH’s FDA HACCP team for both promotion of Risk Management and training of over 1000 individuals.

Jackelyn R. holds a BS in Business Management and is a certified member of the Board of Examiners for the Malcolm Baldrige National Quality Award program.  Jackelyn R. is an ASQ Certified Quality Auditor and an RAB Lead Assessor. She has published numerous validation and compliance-related articles and has been a global industry speaker and presenter on several compliance topics.

EMPLOYMENT HISTORY:

10/04 to Present, Industry Consultant, Marlton, NJ

Jackelyn R. is currently an industry consultant and she is currently serving in a technical and regulatory compliance consultation capacity for several Pharmaceutical, Biologics and Medical Device companies.  Her consulting activities place emphasis on all aspects of FDA Mock Inspections, Implementation of Risk Based programs, delivered public and onsite training thousands of attendees, quality site assessments, regulatory affairs, compliance, regulatory submissions, and various FDA-related activities.

Jackelyn R. provides training, consulting and advisory services to medical device, pharmaceutical, biologics, and biotechnology companies to ensure that the services are designed to leave systems and methodologies in place to establish a sustainable FDA compliance environment.

Jackelyn R. has been an educational Instructor for the Center for Professional innovation & Education over 7 years, and she created and deliver training the following courses; Process Validation,  Introduction to Root Cause Analysis for CAPA, and Reporting Failure Investigations and Process Deviations for Pharmaceutical and Biologic products . Effective Complaint Handling, Overview of Regulatory Requirements for Drugs, Biologics and Medical Devices, Risk Management application within Quality Systems, Quality Audits, and How to prepare for an FDA inspection. (Public as well as on-site trainings).

In addition, Jackelyn R. was an educational Instructor for PTi International for 3 years.  These Courses covered FDA requirements and quality assurance overviews on how to truly understand US Food and Drug Administration requirements for Drugs, Biologics and Devices. Courses also included: Introduction to GMPs for Quality System and Pharmaceutical Regulations (Taught in English and Spanish) These Courses included several chapters designed to provide the learner a step-by-step foundation on 210/211/600/800 GMP/QRS requirements.  Other courses included, Conducting Annual Product Reviews, Mastering Your Performance as a QA Professional, Auditing and Qualifying Suppliers and Vendors, and Overview of International GMPs.

Additionally, as a consultant she has worked with several companies and has been responsible for providing technical, leadership and managerial coordination in establishing, implementing and maintaining new compliance regulatory requirements imposed both from FDA and Notified Bodies.  Some of the current service include: Review of current Quality program compliance to US FDA’s and EU requirements.  Training all levels of personnel to provide a step-by-step foundation for understanding, FDA requirements and quality assurance overviews on topics such as Comprehensive cGMPs, CAPA Program requirements, Complaint handling and root cause analysis, Software and process validation.  Additionally, to performing comprehensive Technical Product design reviews.

10/03 to 10/04, Director of Quality Assurance, Impulse Dynamics, Mount Laurel, NJ

Responsible for providing technical leadership and managerial coordination in establishing, implementing and maintaining new compliance regulatory requirements imposed both from FDA and Notified Bodies.  Responsibilities include working with organizations across the sites to consistently and effectively implement all phases of a QSR/ISO/MDD compliant quality program.

Accomplishments include:

• Directed the Implementation of Compliance Training program for both the U.S. and South America facilities.
• Managed the Validation of the entire manufacturing site in South America, including, IQ, OQ, and PQ process validation activities for a class III implantable device.
• Revamp several processes such as, Compliance training, internal and external Audits, Process Validation and Risk Management.
• Create procedures and systems for several processes such as, Process and Design FMEA, Design Control, Process Validation Document Control and Process Validation

04/01 to 10/03, Director of Quality Systems Regulatory Compliance, Medtronic MiniMed, Northridge, CA

Responsible for providing technical leadership and managerial coordination in establishing, implementing and maintaining new regulatory requirements imposed from Medtronic Corporate, FDA and Notified Bodies.  This includes the implementation and deployment of ISO13485/2003 (both for EU and Canadian requirements), as well as procedures to address 21 CFR Part 820, 210, and 211 requirements.

As the Director of Quality Systems and Regulatory Compliance for Medtronic MiniMed, she was responsible for establishing and crating the necessary quality systems (documented procedures and process) to address FDA requirements for both the Pharmaceutical, Device, and combination products sides of the business.

Also manage the Audit Department, Software Validation Department, Compliance, and the Metrology Department.  Continue to oversee and support the software validation process for the ERP System, as well as the development of the quality systems required to comply with Pharmaceutical regulations for the insulin products.

Responsibilities included working with organizations across the site to consistently and effectively implement the major phases of the 21CFR11 program, which includes training and system inventory, assessment and prioritization.

Accomplishments include:

• Completely revamped and enhanced the operational effectiveness of the Quality Documentation System for a Billion Dollar Corporation in under 9 months.
• As a result of the Quality systems revamp, the internal audits findings were reduced by 81%.
• Revamp several processes such as, Management Review, Internal Audit Program, Process Validation, Risk Management, Training,  and Quality Systems Software Validation and COTS systems.
• Directed all software validation activities related to the implementation of a new ERP Software Program/system for over 1600 users.
• Directed the Implementation of Compliance Training program for over 1600 employees.
• Managed the validation of the multi million dollar ERP System, including, IQ, OQ, and PQ.  in under 7 months
• Spearheading the 21 CFR Part 11 Compliance Program, which included support of site activities pertaining to the 21CFR11 (Electronic Records/Electronic Signatures) Compliance Program.
• As the Privacy Team Representative (to Corporate), lead the implementation of the HIPAA compliance project for a Covered Entity.
• Spearheaded and facilitated Executive Management team with the development and creation of Medtronic MiniMed’s business scorecard. This new business scorecard was used as the gold-standard for other Medtronic business units.
• Managed the Corporate Policies Compliance Training Plan and deployed and Corporate Policies Compliance Training program.
• Directed the effort to generate several procedures and processes such as, Process and Design FMECA, and Process Validation.

03/95 to 04/01, Quality Systems and Regulatory Affairs Senior Manager, BioEnterics Corporation, Carpinteria, CA        

Responsible for managing the Quality Assurance/Control, Regulatory Affairs, Sterilization, Microbiology, Environmental monitoring, both Vendor and Internal Audits, Process Engineering, Quality Engineering, Metrology, and Document Control Departments.  Responsible for the set-up of the Medical Device Vigilance System, Post-Market Surveillance, Technical Files, Document Control, Metrology, Return Product Systems

Fully responsible for fulfilling all requirements imposed by FDA and BioEnterics’ Registrar and Notified Body including correlation of all surveillance audit responses and follow-up to any nonconforming reports issued during FDA’s site inspections and surveillance audits, and other communications to Notified Body and FDA.

Managed global regulatory submissions to insure all documentation met US, Canadian, and European regulatory standards including:

Ensure all documentation met US, and European regulatory standards (ISO/EN & MDD) Interact with FDA and International Regulatory Agency officials

Provided regulatory assessment of technical support required to gain pre-market clearance/approval.

Reviewed and approved all Technical file Dossiers in order to comply with the Medical device Directive for all class I, II, & III products for CE Marking. Reviewed and approved 510(K), IDE, and PMA submissions as well as Facility and product registration. Including, review and approvals of regulatory submissions to ensure company’s strategies, and ensured that proper elements were prepared accordingly and in advance of regulatory submissions.

• Generated 90% of all required ISO/EN procedures for the ISO9001, EN46001, and Medical Device Directive requirements to complete the whole certification program, and set up and headed the Steering Committee.
• Completed the implementation of the quality systems required for ISO9001, EN46001 and the MDD to achieve compliance certification status within a ten-month period.
• Directed the implementation of several cost-saving programs and quality initiatives’ to enhance efficiency, such as, the implementation of lean manufacturing projects, which resulted in a 70% cycle time reduction for the manufacturing process of a class II implantable device.
• Reduced the complexity of quality system processes and documentation –by improving, streamlining and implementing a paperless document routing and approval system.
• Streamlined QC inspection processes by eliminating non-value-added operations, and implemented several quality initiatives to improve operational effectiveness and efficiencies, which resulted in the PMA inspection being waived by the FDA’s CDRH Office of Compliance.
• Created and implemented a HACCP plan for a long term implantable device
• Responsible for coordinating a meeting with FDA’s top CDRH officials for the purpose of obtaining feedback so that BioEnterics could include a HACCP Plan in their Manufacturing (modular) PMA submission.
• Created the following comprehensive processes: Facility and Equipment Validation, Sterilization, Environmental Monitoring,  Shipping, Purchasing, Document Control, Supplier/Subcontractor Assessment, Vendor Audits, Control of Nonconforming Products, Management  Controls, Medical Device Vigilance and Corrective Action Procedures,

Other Accomplishments:

• Assisted the Food and Drug Administration HACCP Cadre in teaching (over 1000 people) both industry and FDA officials the principles of HACCP and Quality System Regulations.
• From April 1999 through June 2001, worked with the FDA in their pilot study created to introduce the new Hazardous Analysis & Critical Control Points (HACCP) Inspection technique to the Medical Device Industry.
• I have participated/instructed at the National FDA Medical Device Process Validation Training Course, 06/01(for FDA investigators only).
• I have published numerous validation and compliance-related articles and I have been a global industry speaker and presenter on several compliance topics.

CURRENT CERTIFICATIONS/AFFILIATIONS:

• Bachelor’s Degree (Business Management) University of Phoenix.
• In 1999 served as a Certified member of the Board of Examiners for the California Quality Award.
• In 2000 served as a Certified member of the Board of Examiners for the President’s National Quality Award.
• In 2001, 2002, 2003, and 2004 served as a Certified member of the Board of Examiners for the Malcolm Baldrige National Quality Award.
• Currently serve on the Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT)
• ASQC Certified Quality Auditor, CQA Certification No. 17390
• RAB ISO Lead Assessor Certification -
• Completed Six-Sigma Champion training – 2003