This qualified expert has been involved in the field of medical technologies for over forty years and is experienced with matters concerning FDA compliance on which he has authored several articles and papers and given talks on FDA compliance worldwide. He is also the vice president of a private medical technologies firm, making him intimately qualified to comment on the case at hand.
- Location: New York
- B.S., Biology, City College of New York
- Graduate Studies in Regulatory Affairs
- Certification: RAB International Certificate Lead Assessor for ISO 9000./ISO 13485
- Member, Editorial Review Board for the Journal of cGMP Compliance.
- Former, Supervisor of Field Investigations, US Food and Drug Administration
- Former, US FDA Advisory board member for HACCP as an inspectional approach
- Current, Executive VP, private medical technologies firm
- Audited over 400 pharmaceutical and medical device manufacturers worldwide for FDA compliance
- Participated in over 400 FDA GMP audits of FDA regulated companies, Pharmaceuticals, Devices, Foods and Blood Banks in the USA and worldwide
- Set up over 400 Quality System for both QSR/cGMP compliance and/or ISO13485 certification and ISO9000 certification.
- Published, 14 papers and articles on FDA compliance matter.
- Serviced as expert witness on various cases, giving strategic planning, depositions and testify.