North Jersey Section – Data Integrity: A Global Regulatory Survey with Emphasis on Excipients

Featuring Dr. Irwin Silverstein

Dr. Silverstein is a consultant in Quality and regulatory compliance with an emphasis on pharmaceutical excipients. He has been a sub-contracted expert consultant where pharmaceutical companies are involved in Consent Decree with the FDA

 Formerly the ISP Corporate QA Director, he has worked since 1991 with IPEC to develop appropriate GMP requirements for excipients. He is currently the chair of the IPEC-Americas Training Team. He was VP and COO of International Pharmaceutical Excipients Auditing and achieved ANSI accreditation in 2010 for the IPEA Excipient GMP Certification program.

 Dr. Silverstein is a member of the NSF committee that wrote the American National Standard (ANSI) for Excipient GMP. He is also performing dietary supplement verification audits for USP.