Our Consultants


The Best & Brightest FDA Consultants

Below, you will find representative CVs of the experts The FDA Group has within its organization. With a staff that reaches all corners of the world, we are sure to have the appropriate resource for your project.

Select (or slide to) a category above to display the associated CVs below.

Once selected, hovering your mouse over the CV displayed below will pause rotation.
To continue rotation, simply move your cursor away from the CV or drag/slide to another category above.

Director of QA/RA

  • FDA’s QSR/GMPs – 21 CFR Parts 600, 210 & 211, 600, 820, 806, 7, and 11
  • Quality Systems and Systems-based Implementation & Auditing
  • Post-Market Surveillance and Vigilance
  • Canadian Regulations for Medical Device, Pharmaceutical, and Biologics Industries
  • Facilitating responses to address FDA-483s and Warning Letters
  • ERES and Documentation Systems
  • Risk Management / hazard analysis
  • Lean Manufacturing and Six-sigma
  • ISO 9001 / 2000, 13485 / 2003
  • Technical Files Compilation
  • Supplier Quality Assurance
  • MDD/IMDD requirements
  • Compliance Inspections
  • Documentation Systems
  • Quality Engineering
  • Process Validation
  • HIPAA requirements
  • Mock FDA inspections
  • CE-Marking
  • Pre-Approval and Readiness Assessments

This resource has over 30 years’ experience in all facets of Quality Assurance and Regulatory Compliance.  This resource 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, she has created and implemented entire Quality Systems for several Pharmaceutical, Biologics and Device companies. This resource also has extensive knowledge of Compliance- Mock 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.

Performed full on-site assessment/audit of an API and Aseptic filling manufacturers covering all areas of the Quality Assurance, Quality Control , Manufacturing, Equipment Qualification and Software and Process  Validation,  Chemistry, and microbiology laboratories in relation to the site’s GMP Compliance.  Resulting in the Reports of “readiness” or gaps in compliance and provided recommendations for any remediation requirements

Her wide-ranged experience and recognized expertise in these areas have acquired her guest speaker positions worldwide, which include several FDA validation workshops (for FDA investigators), and has teached hundreds  of public and onsite CAPA and Process Validation courses for Pharmaceutical, Biologics, and Medical Device manufacturers.   She has worked closely with CDRH's FDA HACCP team for both promotion of Risk Management and training of over 1000 individuals.

This person 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.

This person holds a BS in Business Management and is a certified member of the Board of Examiners for the Malcolm Baldrige National Quality Award program.  She 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

This resource 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.

This resource 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.

This resource 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.

In addition, this person 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.  This resource has delivered hundreds of public as well as on-site trainings (performed worldwide).

This resource has been a Director of Quality Assurance, Regulatory Affairs, Regulatory and Compliance Impulse for several Medical Device, Pharma, and Combination products Manufacturers’ including (startup, medium and Multi-billion dollar Corporations such as Medtronic)

Accomplishments:

Ø  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. 

  • Participated/instructed at the National FDA Medical Device Process Validation Training Course, 06/01(for FDA investigators only).
  • 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. 
  • 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
  • Completely revamped and enhanced the operational effectiveness of the Quality Documentation System for a Billion Dollar Corporation in under 9 months.
  • Directed all software validation activities related to the implementation of a new ERP Software Program/system for over 1600 users.
  • Managed the validation of the multimillion 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.
  • Completely revamped and enhanced the operational effectiveness of a GMP/ISO9000/9001/ 13485 Quality Documentation System for a Billion Dollar Corporation in less than 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. 
  • Created and implemented a HACCP plan for a long term implantable device
  • 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

 

CURRENT CERTIFICATIONS/AFFILIATIONS:

Ø  Bachelor's Degree (Business Management) University of Phoenix.

Ø  In 1999 served as a Certified member of the Board of Examiners for the California Quality Award.

Ø  In 2000 served as a Certified member of the Board of Examiners for the President’s National Quality Award.

Ø  In 2001, 2002, 2003, and 2004 served as a Certified member of the Board of Examiners for the Malcolm Baldrige National Quality Award.

Ø  Currently serve on the Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT)

Ø  ASQC Certified Quality Auditor, CQA Certification No. 17390

Ø  RAB ISO Lead Assessor Certification -

Ø  Completed Six-Sigma Champion training – 2003