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,
Executive 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
