Description

As described in the morning session, regulatory expectations continue to evolve given the complexities associated with new products and innovation. This session will provide an opportunity to hear more about this topic in the context of an innovative vaccine facility and related sterile manufacturing requirements.

Moderator(s):

• Stephen Mahoney, JD, Senior Director, Global Quality & Compliance, Genentech, A Member of the Roche Group

Speaker(s):

• Maria Hoffman, Executive Director, Supply Chain Management, Merck & Co., Inc.
• Patricia Hughes, PhD, Branch Chief, Division of Microbiology Assessment, CDER/FDA