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Expert Profile


Fredric Richman
Consultant, Compliance Achievers, LLC

Fred Richman’s background, expertise and extensive knowledge of the U.S. Food and Drug Administration (FDA) has permitted the clients of his firm, Compliance Achievers LLC (www.complianceachievers.com), to become compliant with drug GMP regulations, assisting them in interacting with FDA during compliance inspections, preparing comprehensive responses to FDA’s FD-483 observations, and in attending regulatory meetings with FDA. In his work, Mr. Richman reviews and advises firms on applicable ICH and FDA guidance documents and GMP regulations regarding quality systems, stability data, process validation, and laboratory controls. He routinely provides assistance on import-export issues.

After having served in FDA field positions of Investigator and Compliance Officer, Mr. Richman began his FDA headquarters career as a Senior Case Review Officer in FDA’s Office of Enforcement, where he was responsible for reviewing and clearing for the Office of the Commissioner, legal action recommendations submitted by FDA field offices nationwide. In 1996, Mr. Richman took on the position of Team Leader for the Adverse Drug Reaction and Pharmacy Compounding Team in FDA’s Center for Drug Evaluation and Research (CDER). In his subsequent CDER position as Deputy Director, Division of New Drugs and Labeling Compliance, he supervised regulatory operations relating to Rx and OTC drugs. He was instrumental in developing a regulatory strategy to address the marketing of unapproved drug products. In 2005, Mr. Richman became the Director of the Division of Compliance Management and Operations (DCMO) in FDA’s Office of Enforcement, providing oversight for the review and clearance of proposed legal actions submitted by field offices, supervising the review and preparation of regulatory actions to address violations disclosed during Team Biologics inspections, and overseeing the nationwide activities of field office recall coordinators. His Division also assisted field Compliance Branches in developing regulatory strategies to address specific violative situations.

Mr. Richman has made numerous presentations to groups such as the Regulatory Affairs Professionals Society (RAPS), the Drug Information Association (DIA), the Pharmaceutical Education Research Institute (PERI), and the Food and Drug Law Institute (FDLI) on diverse drug and device compliance issues. Mr. Richman was recently selected by the Food and Drug Law Institute (FDLI) to serve on its new Global Committee. This committee is charged with assisting FDLI staff in developing and delivering international educational conferences and publications. For the past year, Mr. Richman has also served as Senior Advisor for Pharmaceuticals and Medical Devices for the Transnational Strategy Group LLC, a Washington, D.C. based international trade and business development firm.

Mr. Richman obtained a B.A. degree in Chemistry from Queens College of the City University of New York, Flushing, New York, and an M.S. degree in Chemistry from St. John’s University, Jamaica, New York.

Trainings by Expert

FDA Regulatory Actions: It's Not Just about Warning Letters
Category: Drugs and Chemicals (Pharma) , Medical Devices , Clinical Research , Biotechnology , Laboratory Compliance , All FDA Regulated Industry , All FDA Regulated Industry , FDA Audit and Inspection , Documentation and IT , Audits & Inspections , Laboratory , Food & Dietary Supplements , Drugs Regulations , Clinical Trial Regulations , Biotech Regulations , Audit & Inspection-Role , Food Safety Audit , All FDA Reg. based Audit , Medical Device Inspection , Lab Audit , Drugs Inspections , Clinical Research Audit , Documentation and Policy Management , Lifescience process & Procedures , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management , Common FDA Regulations