About the Workshop Leader

Irwin Silverstein, Ph.D., is Chief Operating Officer of International Pharmaceutical Excipients Auditing Inc. (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 13 years with the International Pharmaceutical Excipients Council of the Americas (IPEC-America) developing excipient GMP guidance documents and representing the organization at Food & Drug Administration meetings and various conferences.

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. Using his 20 years of experience in pharmaceutical ingredient quality systems, Dr. Silverstein also has become a consultant to both pharmaceutical and excipient manufacturing companies.

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) and Tablets & Capsules (July). 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.