Industry Consultant (Former FDA)


More than 30 years of experience auditing Pharmaceutical, Medical Device, Biologic and Biotechnology product manufacturers worldwide. Also has two years experience working in an FDA Microbiology Laboratory where he began his FDA career.  His FDA Investigator career began in pharmaceutical inspections, and while working in this capacity, he received additional training in antibiotics, radiopharmaceuticals, parenterals, sterilization, clinical/ non-clinical (GLP) laboratory studies, computer systems validation and pharmacology. Was located in the Buffalo District and served as the District Drug Expert.  His responsibilities included conducting FDA Pre-Approval Inspections and Good Manufacturing Practices Inspections of drug and biologic products.  Also performed audits of Clinical Investigators, Institutional Review Boards and Bioequivalency testing.  He was selected as a Foreign Inspection Cadre member in 1978 and conducted numerous inspections of foreign Pharmaceutical, Medical Device and Biologic product manufacturers. He was selected as a member of Team Biologics in 1999 and performed inspections of licensed Vaccine, Biotechnology and Blood Fractionation products. He received additional training provided by CBER in the manufacture, quality control and testing of viral and bacterial vaccines, biotechnology and blood fractionation products.  Received a B.A. in Psychology from the State University of New York.


Assessment of Biologic, Biotechnology and Pharmaceutical manufacturing operations for compliance with CGMPs



Aug. 2014 – Present  Industry Consultant


Jan 2008 – Aug. 2014 Principal Consultant


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


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.




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.

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