Regulatory Expertise:
Quality System Development/Implementation, Bioresearch Audits-Clinical Investigator/IRB/Sponsor, GMP Audits, Food-HACCP, Training
WORK EXPERIENCE:
April, 2004-Present Industry Consultant
Rockwall, Texas
Representative projects include:
March 2008-October 2008
Worked with a manufacturer of Dialysis solutions and concentrates who was the recipient of a Warning Letter . Work involved conducting internal audits of three different manufacturing sites to bring them into compliance with the Quality System Regulation. Work additionally consisted of writing Standard Operating Procedures. A written response was drafted to respond to the Warning Letter.
February, 2008 Worked with an importer/manufacturer of Chinese crude Heparin. Work involved inspection of Chinese processing facility following the FDA inspection in China. Assisted in responding to the FDA-483 that was issued to the Chinese facility.
March 2007-November, 2007
Worked with a large manufacturer of O-T-C drugs and vitamins/minerals who was the recipient of
a Warning Letter from the United States Food & Drug Administration. Work involved reviewing
manufacturing records for completeness and compliance with Good Manufacturing Practice
regulations. Work also consisted of reviewing and re-writing Standard Operating Procedures to
bring them into com pliance with existing regulations.
April 2005-January 2007
Working with large manufacturer of catheters, stents, and drug coated stents, and associated cardiac related devices. Work consists of FDA Readiness Training, QSR training, GLP training and conducting mock FDA Audits. Work is in both the U.S. as well a Europe and South America. The work is in response to the firms’ receipt of several Warning Letters.
December 2004-Feburary 2005
Worked with large IVD manufacturer both in the U.S. and Australia in responding to a Warning
Letter. Work consisted of review of batch records, CAPA reports and conducting Gap Assessments in preparation for FDA follow-up. Additionally, conducted a due diligence audit of a firm in Australia prior to acquisition.
April, 2004- Sept. 2004
Worked with with a large manufacturer of catheters, implantable ports/manifolds and devices including bare as well as drug coated stents. Work consists of conducting classroom and 1 on 1 training in dealing with the FDA during inspections. Various sites were audited to determine their compliance to current QSR and ISO requirements.
Worked with large manufacturer of: in-dwelling catheters, pumps and ventricular assist devices. Involved in revising their Quality System to comply with QSR and ISO requirements, as well as “Best-In-Class”. Worked primarily with Supplier Materials and Material Controls, as well as internal and supplier audits.
Worked at a large manufacturer of coronary stents and stent delivery systems as Acting Director of Quality Assurance. Work involved review and approval of Corrective and Preventive Action Reports, Document Control Records, Non-conformance Reports, Laboratory Investigations, Failure Analysis Reports and Customer Complaints. Work also consisted of preparing the manufacturing location for an upcoming inspection by the U.S. Food & Drug Administration.
Worked with clients in the medical device and pharmaceutical industries to develop quality assurance, manufacturing, and regulatory strategies for compliance with FDA regulations by:
- Conducting assessments of client studies, procedures, and programs to determine compliance
- Assisting with development and implementation of quality systems
- Developing and implementing corrective action plans to address deficiencies
- Conducting GMP audit/mock FDA inspections
2000-March, 2004 Consulting agency, Rockville, MD
(Rockwall, TX based)
Associate Director of Quality Systems
Worked with clients in the medical device and pharmaceutical industries to develop quality assurance, manufacturing, and regulatory strategies for compliance with FDA regulations by:
- Conducting assessments of client studies, procedures, and programs to determine compliance
- Assisting with development and implementation of quality systems
- Developing and implementing corrective action plans to address deficiencies
Representative projects have included:
GMP audit/mock FDA inspection at an optical laser manufacturer in Europe prior to the firm being inspected by FDA as part of a pre-PMA Approval Inspection. Mock FDA 483 findings were presented, along with criticality assessments and recommendations for correction. Additionally training was presented to the firm on “Logistics of an FDA Inspection”.
Worked at a large IVD manufacturer under Consent Decree. Involved in Quality Systems development and product and process validations using a Risk-based approach. Conducted many “FDA Interface” type-training sessions to employees who will come in contact with FDA investigators as part of their daily activities during a FDA inspection.
GMP audit/mock FDA inspection at a large infant formula manufacturer who produced both thermally processed and aseptically filled infant formulas. Mock FDA 483 findings were presented, along with criticality assessments and recommendations for correction.
Worked at a large manufacturer of Glucose monitoring devices under Special Conditions of Probation. Involved in development of an FDA Inspection Readiness Team along with conducting mock FDA type inspections of the firm’s manufacturing operations both at domestic and foreign locations. Conducted many FDA Inspection Readiness training sessions at both the domestic and foreign locations. Involved in Quality Systems development of various aspects of the firm’s products and processes using a Risk-based approach.
Worked at a large manufacturer of coronary stents who was in the process of developing a drug coated/drug eluting stent prior to submission to the United States Food & Drug Administration for approval. Work involved conducting due diligence audits of contract manufacturing sites at both domestic and foreign locations. Work involved the review of Quality Systems processes such as product/process validation, vendor approval/qualification, design control, batch record review and operating procedure development.
Conducted mock FDA inspection of a large central laboratory that conducts analysis of blood, serum and urine samples. This central laboratory conducts the assays as part of on-going clinical studies which are part of drug manufacturers drug approval processes. This mock inspection covered Good Laboratory Practices and Quality System Regulation
Worked at large pharmaceutical manufacturer that was under Consent Decree. Work involved doing third party review and certification of Batch Production Records, Laboratory Investigations, Corrective and Preventive Actions, and Customer Complaints.
1962-1999 U. S. Food and Drug Administration, Phoenix, AZ/Detroit, MI/Minneapolis, MN
Senior Investigator, Los Angeles District/Phoenix Resident Post (1987-2000)
District and Regional Health Fraud Coordinator, Los Angeles District (1990-2000)
Investigator, Detroit District (1966-1969)
Resident-in-Charge, Detroit District/Saginaw Resident Post (1969-1987)
Investigator, Minneapolis District (1962-1966)
Conducted regulatory investigations in the areas of medical devices, compressed medical gases, clinical research investigators, good laboratory practices, institutional review boards, dietary supplement manufacturers, source plasma centers, cosmetic manufacturers, and food processors.
Involved in the coordination of an annual meeting between the FDA District offices of Los Angeles, San Francisco, Denver, and the state agencies in Arizona, Nevada, Utah, and New Mexico.
Managed seven investigators conducting criminal investigations of firms and individuals operating in Arizona, California, and Nevada.
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.
Reviewed the investigations of fraudulent human drug and medical device to determine next step. Involved in the writing of Warning Letters to fraudulent parties.
As member of New Hire Training Cadre, facilitated the training of new investigators. Decided when to retain or dismiss new hires.
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 annual work plan and schedules of inspections of over 150 FDA regulated firms in Central and Northern Michigan. These firms were engaged in acidified and low acid food processing, medical devices, bulk pharmaceuticals, good laboratory practices, clinical investigations, source plasma collection, blood collection and processing, and veterinary drugs, and fish processors.
Conducted plant inspections, sample collections and special investigations. Areas of specialization included acidified and low acid food processors, dairy processing plants and fish processors.
TRAINING:
FDA Sponsored Training
Medical Devices
Statistical Quality Control
Basic Course Medical Devices
Process Validation
Biologics
Advanced Course Blood Banks
Regional Blood Bank School
Computer Aided Blood Bank Inspections
Blood Banking and Plasma Collection
Drug School
Basic Drug School
Advanced Drug School
Non-Clinical Bioresearch
Courtroom and Witness Seminar
Criminal Investigations
AWARDS AND HONORS:
Numerous “Outstanding” Performance Ratings
Commendable Service Award for work performance and training employees
Many “Group Performance Awards”
Cash Awards for “Individual Accomplishments”
EDUCATION:
1962 B.S. Fish and Wildlife Management, Iowa State University, Ames, Iowa 10/2001