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 has worked as a consultant. He has been a subcontractor to a consulting firm hired as expert consultants by pharmaceutical firms in consent decree with the FDA. Currently, he has continued to work with the International Pharmaceutical Excipients Council of the Americas (IPEC) since its founding in 1991 and 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 the development of workshops, webinars, and eLearning.
