Dr. Gold has a wealth of experience and achievements in the regulatory compliance field, including: Appointed to FDA’s Pharmaceutical Science Manufacturing Subcommittee; Recipient of the PDA Distinguished Service Award; Originated and have taught professional courses to more than 2100 industry; FDA and other Board of Health representatives in the US, Europe and Asia over the past eighteen years; Routinely teach FDA Investigators advanced topics at FDA ORAU; Developed the rationale and criteria for all corporate Lederle and Par process validation programs covering active pharmaceutical ingredients, oral, topical and parenteral dosage forms; Developed the rationale and criteria for all corporate Lederle and Par qualification and validation procedures for processing equipment, laboratory equipment, computer systems, water systems, HVAC, equipment cleaning and product packaging.

Dr. Gold is actively involved in the industry including: Member of FDA Manufacturing Subcommittee of the Advisory Committee for Pharmaceutical Science, 2003-Present; Product Quality Research Initiative Drug Substance Technical Committee Member, 1997-Present; Chair of PDA Committees responding to the 2001 ICH Q7A Guidance for Active Pharmaceutical Ingredients, the 1998 FDA BACPAC I Guidance, the 1996 and 1998 FDA Guidance for Industry on Manufacture, Processing or Holding of Active Pharmaceutical Ingredients and the 1997 PIC-PIC/S Internationally Harmonized Guide for Active Pharmaceutical Ingredients; Chair of the Operations Section of PhRMA for two years; PhRMA Operations Section Executive Committee member for seven years; Chair of PhRMA Bulk Pharmaceutical Chemicals Committee for two years; PDA Board of Directors Member for three years; Chair of PDA International Congress, Osaka 1997; Chair of first Annual FDA/PDA Joint Meeting, 1992; Chair of PhRMA Committee responding to 1984 FDA Guide to Bulk Pharmaceutical Chemicals Manufacturing.

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