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The risks related to the manufacture of sterile drug products remained an obstacle as health and safety considerations, travel restrictions, and additional challenges were introduced by the COVID pandemic. Despite the COVID-related challenges, there was continual discussion surrounding the evolving regulatory expectations for mitigating the risks associated with sterile drug manufacturing operations and the efforts to better understand the best practices for ATMP operations. These are just two examples of the topics involved in this ongoing discussion.
This session will provide insights, related enforcement actions, and case studies from CDER and CBER speakers, along with an update and discussion of the status of Annex 1. In addition, this session will highlight discussions related to Containment Control Strategy (CCS) and include an update on the development of the upcoming PDA Technical Report for CCS.
Douglas A. Campbell
Senior Consultant
InterPro QRA
Chester, Maryland, United States
Biswarup Dasgupta, MS
Quality Professional
NA
Lynnfield, Massachusetts, United States
Glenn E. Wright, MA
Vice President, Scientific and Regulatory Affairs
PDA
Bethesda, Maryland, United States
Brooke K. Higgins, MS
Senior Policy Advisor, CDER
U.S. FDA
Midlothian, Virginia, United States
Simone E. Pitts, MS
National Expert, Pharmaceutical, ORA
U.S. FDA
Bridgeport, Connecticut, United States