Irwin B. Silverstein, Ph.D.

Lead Trainer
IPEC-Americas Excipient Learning Lab

Irwin is a consultant to IPEC and the excipient industry specializing in quality assurance and regulatory compliance for pharmaceutical excipient ingredients. He also has experience in areas of quality assurance for API, medical device and drug products.

For 17 years he was Corporate Director of Quality Assurance for International Specialty Products (ISP) with responsibility for their excipient, API, and medical device products. Since 1991, he has worked with the International Pharmaceutical Excipients Council (IPEC) developing guidelines for excipient GMP compliance and has represented IPEC at various conferences and at the Food & Drug Administration. Dr. Silverstein established an excipient GMP certification program that was accredited by the American National Standards Institute (ANSI) and ran the program from 2001 till 2014.

His consulting also includes conformance assessments to site requirements for pharmaceutical manufacturers (finished drug makers). He performs gap analyses with respect to excipient GMP compliance for excipient manufacturers and has provided detailed guidance as to how to improve their conformance to excipient GMP requirements. He is an American Society for Quality (ASQ) Certified Quality Auditor (CQA) as well as ISO 9000 Certified Lead Auditor. He helped develop the IPEC-Americas auditor training programs for hourly and supervisory personnel. Irwin also serves as leader of the IPEC-Americas Excipient Learning Lab (ELL).