Validation of exchange able modules

Dr. Bernard Shamsai

Dr. Bernard Shamsai is currently serving as Head of Validation for Gilead Sciences, La Verne, California. In this capacity, he is responsible for overseeing all validation activities, including qualification of aseptic processes, manufacturing processes, manufacturing equipment and sterile facility. Prior to Gilead, Dr. Shamsai worked at Teva Pharmaceuticals as Senior Director, Global Process Engineering. At Teva, he provided technical oversight on a broad array of activities, including late stage technology transfers, process development and qualification of complex injectable products, and manufacturing equipment design and qualification. He also led the development team for Generic EpiPen. Prior to Teva, Dr. Shamsai oversaw the design and construction of a new commercial manufacturing facility for Amylin Pharmaceuticals in West Chester, Ohio, to produce extended release formulation of exenatide.

Dr. Shamsai has over 20 years of post-doctorate industrial experience in pharmaceutical industry. He holds a Ph.D. in Chemical Engineering from UCLA and a B.S. degree in Chemistry from University of Southern California.