Description

Innovation in Technological Platforms in Biopharmaceutical

Plenary Session - Innovation in Technological Platforms in Biopharmaceutical Manufacturing 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.

• Process and Facility Innovation using PODs in Vaccine Manufacturing – Benefits and Challenges
  Maria Hoffman, Executive Director, Supply Chain Management
  Merck  
• Innovations in Sterile Manufacturing – Regulatory Considerations
  Patricia Hughes, PhD, Branch Chief, Division of Microbiology Assessment
  CDER, FDA