PRIMARY EXPERTISE
Assessment of Biologic, Biotechnology and Pharmaceutical manufacturing operations for compliance with CGMPs
EXPERIENCE
Aug. 2014 – Present Industry Consultant
Jan 2008 – Aug. 2014 Principal Consultant
PAREXEL
Amherst, New York
Provided a wide range of consulting and auditing services to clients, specializing in cGMP compliance issues with Quality Systems in Biologic, Biotechnology and Pharmaceutical product manufacturing. Services provided included assistance drafting responses to FDA 483 Observations and FDA Warning Letters issued for non-compliance with CGMPs. Assisted in identification and performance of remediation actions for non-compliance with CGMPs. Served with other Consultants to provide a broad range of services designed to assist clients in achieving general compliance with FDA regulations.
2002 – Dec 2007 Senior Consultant
PAREXEL
Amherst, New York
Positions Held Prior to PAREXEL Consulting:
1999 - 2002 Member of Team Biologics
U.S. Food and Drug Administration
Buffalo, New York
Performed CGMP inspections of domestic and foreign Biologic and Biotechnology manufacturers of Vaccines, Therapeutic Drugs and Human Plasma Fractionation products. Provided training to other less experienced FDA Investigators. Evaluated manufacturing processes including cell culture and fermentation, contamination control, aseptic processing, manufacturing process validation, purification processes, lyophilization processes, bacterial and viral inactivation processes, barrier filling systems, potency & stability testing, investigations of manufacturing deviations and laboratory OOS. Obtained evidence used by FDA to take regulatory action.
1979 – 1999 FDA Pharmaceutical Investigator
Performed numerous CGMP inspections of domestic and foreign Pharmaceutical manufacturers. Inspected manufacturers of Sterile Injectable products, Sterile Bulk Antibiotics and Bulk Drug Substances, Aerosol Inhalation products, Topical products, Oral liquid products and Solid dosage form products. Provided training to other less experienced FDA Investigators. Evaluated aseptic processing facilities, water for injection systems, sterilization processes, lyophilization processes, manufacturing process validation, fermentation and purification processes, bulk drug substance synthesis, chemistry, microbiological and animal laboratories, and associated Quality Control/Quality Assurance systems. Performed inspections of laboratories conducting clinical and non-clinical testing in support of FDA submissions. Also performed Hazard Analysis and Critical Control Point inspections of Low Acid Canned Food and Infant Food manufacturers for compliance with established regulations. Obtained evidence successfully used by FDA to seize/recall drug products, to place foreign manufacturers on Import Detention, enjoin management from violating the FD&C Act, prosecute responsible management, and to support NDA/ANDA turndowns/revocations.
1978 FDA Foreign Pharmaceutical Inspection Cadre Member
Began cGMP inspections of worldwide Pharmaceutical manufacturers.
1972 – 1977 FDA Investigator
Performed numerous CGMP inspections of domestic Pharmaceutical manufacturers. Evaluated facilities, equipment, manufacturing operations, written procedures, master & batch production records, laboratory equipment & test methods, and NDA/ANDA commitments. Obtained evidence successfully used by FDA to seize drug products and enjoin management from violating the FD&C Act.
1970 – 1972 FDA Analytical Laboratory
Participated in analysis of adulterated/misbranded products.
EDUCATION
B.A.
State University of New York
Attended extensive FDA sponsored CGMP training conducted by various universities including University of Rhode Island, University of Houston and University of Tennessee. Attended Federal Law Enforcement Training Center, Glynco, Georgia.