About the Workshop Leaders
Irwin Silverstein, Ph.D., is Chief Operating Officer of IPEA. Previously he was corporate director of quality assurance for International Specialty Products with responsibility for excipient, API, and medical device products. He has worked over 15 years with IPEC-Americas developing excipient GMP guidance documents. Dr. Silverstein holds both an American Society for Quality (ASQ) Certified Quality Auditor (CQA) and ISO 9000 Certified Lead Auditor (CLA) status. In addition, Dr. Silverstein is president of his own firm, IBS Consulting in Quality, LLC, which specializes in quality assurance and regulatory compliance for pharmaceutical excipient ingredients.
Dr. Silverstein has authored numerous articles in industry journals on excipient GMP compliance and auditing. Most recently, his articles have appeared in American Pharmaceutical Review (June '05 and Tablets & Capsules (July '05). Also of note is an article on Quality for the Kirk-Othmer Encyclopedia of Chemical Technology and a chapter on excipients in Validation of Active Pharmaceutical Ingredients
Sidney Goode, Pharm D, RPh, worked with Dow Chemical for thirty eight years holding positions in chemical and toxicology research, product regulatory management, sales/marketing, FDA regulatory compliance management, quality and project management. He also was part of a team that supported the approval of products seeking regulatory acceptance for marketing; a member of the consolidated audit group qualifying and auditing suppliers, quality systems and regulatory compliance with industry standards. His career spanned intervals in the areas of industrial hygiene, medical department administration and environmental compliance. A decade was spent working part time as a co-director of a psychiatric hospital pharmacy participating in clinical trials of potential drugs and treatment regimens.
Sidney is currently working as a consultant concentrating in areas of regulatory and quality compliance in the pharmaceutical, food and associated industries. The activities also include auditing and training working with International Pharmaceutical Excipient Auditing, IPEA Inc. His training includes BS degree in Biology/Chemistry, BS, Pharm D in Pharmacy, and certification in Clinical Toxicology. He has worked with International Pharmaceutical Excipient Council, IPEC, from early formation in the creation and publications of GMP and supporting guidance documents. He has held positions on the Board of Directors, was chair of the GMP Committee for several terms and is currently a board member of IPEA.