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#23: How to Prepare for an FDA Inspection


  • Michael  Hamrell, PhD, RAC

    Michael Hamrell, PhD, RAC

    • President
    • MORIAH Consultants, United States

    Dr. Michael R. Hamrell is the President of MORIAH Consultants, a Regulatory Affairs/Clinical Research consulting firm located near Los Angeles, CA. He has worked in pharmaceuticals, contract research, government and biotech industries, in domestic and international regulatory affairs and clinical research. He also worked in the Division of AIDS in NIAID at NIH and as a reviewer at CDER at the FDA. Dr. Hamrell has published numerous papers in pharmacology, regulatory affairs, product development, clinical research, computers and information systems.