PROFILE SUMMARY
A former FDA Career Officer and over 30 years domestic and international regulatory enforcement experience with the US FDA. He has over 4 years experience in private Quality Systems Regulation and FDA regulatory compliance consulting helping firms meet FDA requirements by conducting pre-FDA visit audits.. Has experience conducting drug inspections in Europe and Asia.
EXPERIENCE HIGHLIGHTS
30-year career with the FDA includes several key positions such as Inspector, Investigator, Supervisory Investigator, Work experience in various FDA Field Districts and HQ offices, across the US and Mexico
Conducted hundreds of investigations and inspections in Drugs (API,OTC ,Finished sterile/non-sterile) and Devices. Perform Inspections in the drug manufacturing of API, Finished dose, sterile filled areas, BIMOs (Drug/Device), Blood Centers, Clinical Investigation, Institutional Review Boards, Contract Research Organizations, GCP/GLP
Led a private US FDA regulatory consulting firm in providing litigation support consulting, auditing consulting and regulatory compliance strategy consulting in the Medical Device, Drug, and Food industries.
Participated in the FDA National New Investigator Training Program, teaching and training new investigators in performing investigations and inspections
Performed six system audits of Drugs OTC and Sterile formulation facilities