B3: Manufacturing during and after the Pandemic

Tuesday, September 28, 2021

15:30 – 17:00 EDT

Moderator(s)

Mary Farbman, PhD

Associate Vice President, Global Auditing and Compliance Support
Merck & Co., Inc.
Newton, Massachusetts, United States

Kathy Demarest

Executive Director, Quality
Amgen Inc.
Cranston, Rhode Island, United States
Thomas Kreil, PhD

Vice President, Global Pathogen Safety
Takeda Manufacturing Austria AG
Wien, Wien, Austria

CDR Tara Gooen Bizjak, MBS

Director, Manufacturing Quality Guidance and Policy Staff, CDER
U.S. FDA
Silver Spring, Maryland, United States

15:30 – 15:51 EDT

"This was their finest hour." -Winston Churchill Manufacturing During a Global Pandemic
Presenter: Kathy A. Demarest – Amgen Inc.
15:51 – 16:09 EDT

Quality Considerations and Verification of SARS-CoV-2 Safety Margins
Presenter: Thomas R. Kreil, PhD – Takeda Manufacturing Austria AG
16:09 – 16:34 EDT

Manufacturing During and After the Pandemic: A Regulatory Perspective
Regulatory Presenter: CDR Tara Gooen Bizjak, MBS – U.S. FDA
16:34 – 17:00 EDT

Live Q&A (B3)
Moderator: Mary E. Farbman, PhD – Merck & Co., Inc.
Panelist: Kathy A. Demarest – Amgen Inc.
Panelist: Thomas R. Kreil, PhD – Takeda Manufacturing Austria AG
Regulatory Panelist: CDR Tara Gooen Bizjak, MBS – U.S. FDA