Course Instructor

Irwin Silverstein, Ph.D.

Consultant to the pharmaceutical industry, Excipient Guidelines and Standards Expert

Irwin Silverstein has been a consultant to the pharmaceutical industry since 2000. His career included 17 years as the head of corporate quality for ISP, a specialty chemical manufacturer that produced excipients and Active Pharmaceutical Ingredients. Since leaving ISP, he works as a consultant. He has been a subcontractor to a consulting firm hired as expert consultants by pharmaceutical firms in consent decree with FDA. Currently, he has continued to work with the International Pharmaceutical Excipients Council of the Americas (IPEC) since their founding in 1991and has been involved in the development of excipient GMPs and related guidelines. He is on the NSF Standards Writing Committee that developed the NSF/IPEC/ANSI 363 Good Manufacturing Practices for Pharmaceutical Excipients ANSI standard. He is also the chair of the IPEC Learning Lab with responsibility for development of workshops, webinars and eLearning.