Daniel Gold D.H. Gold Associates, Inc

Dr. Daniel H. Gold is the President of D.H. Gold Associates, Inc. His company specializes in compliance issues such as facility design and qualification, PAI preparation, process transfer, process computer systems validation, aseptic processing, clinical supplies, laboratory management systems, employee certification programs, DMF and CMC preparation and maintenance. Facility and systems audits are a particular specialty.

Formerly, Dr. Gold was Vice President of Quality at Par Pharmaceuticals, a multi-plant producer of oral dosage drug products. Before working at Par, Dr. Gold was Senior Director at Lederle Laboratories, where he was responsible for validation and manufacturing programs as well as quality assurance programs covering oral and parenteral dosage forms, bulk pharmaceutical chemicals and biologics. Prior to that, Dr. Gold was Operations Manager for Bulk Pharmaceutical Chemicals, also at Lederle Laboratories, producing active ingredient entities for captive use as well as contract sales. Earlier, Dr. Gold served in a variety of R & D and manufacturing positions within American Cyanamid (parent company of Lederle Laboratories) in the chemical and polymer operations dealing with both commodity and specialty chemicals. Dr. Gold received his B.S. from Brooklyn College and his Ph. D. in Physical Chemistry from the Polytechnic Institute of New York. Author of numerous papers and patents, he is currently a member of FDA's Pharmaceutical Sciences Advisory Manufacturing Subcommittee, a past Chairman of the Pharmaceutical Research and Manufacturers of America (PhRMA) Production, Engineering and Materials Management Committee and of the Bulk Pharmaceutical Chemicals Committee. He also chaired PhRMA's joint intersectional committee responding to the FDA in their "Guide to Inspection of Bulk Pharmaceutical Chemicals." Dr. Gold served for many years as an Officer and Chairman of the PhRMA's Operations Section. He also served six years as Director of the Parenteral Drug Association. He chaired the PDA Committee responding to FDA Guidance proposals such as FDA's 1996 "Draft Guidance for the Manufacture, Processing or Holding of Active Pharmaceutical Ingredients," their response to the 1998 "Draft Guidance, BACPAC 1: Intermediates in Drug Substance Synthesis" and also to the ICH 2000 Draft, "Q7A, Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients." Dr. Gold has served as a member of the FDA sponsored PQRI Drug Substances Committee formulating research programs to further advance the science. Dr. Gold is also a recipient of the PDA Gordon Personeus Award.