Session: B3: Manufacturing during and after the Pandemic

Live Q&A (B3)

Tuesday, September 28, 2021

16:34 – 17:00 EDT

This session will focus on some of the many challenges manufacturers face when bringing critical medicines to market during a pandemic. We will focus on concrete strategies firms used during the past year to address high absenteeism, prevent disease spread in their facilities, handle supply chain disruptions, and determine what work could be managed from remote settings. In addition, the session will focus on how firms assessed their current microbial controls strategies for effectiveness in preventing entry of SARS-CoV2 particles into their production streams. Finally, we will discuss the regulatory expectations for manufacturing during times of high absenteeism and under pandemic conditions.

Moderator(s)

Mary E. Farbman, PhD

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

Panelist(s)

Kathy A. Demarest

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

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

Regulatory Panelist(s)

CDR Tara Gooen Bizjak, MBS

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