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Track: SUPPLY CHAIN & MANUFACTURING CHALLENGES

B5: Sterile Drug Hot Topics

Wednesday, September 29, 2021

13:45 – 15:15 EDT

Moderator(s)

Douglas Campbell

Senior Consultant
InterPro QRA
Chester, Maryland, United States

Panelist(s)

Biswarup Dasgupta, MS

Quality Professional
NA
Lynnfield, Massachusetts, United States
Glenn Wright, MA

Vice President, Scientific and Regulatory Affairs
PDA
Bethesda, Maryland, United States

Presenter(s)

Biswarup Dasgupta, MS

Quality Professional
NA
Lynnfield, Massachusetts, United States

Presentation Handout

Regulatory Panelist(s)

Brooke Higgins, MS

Senior Policy Advisor, CDER
U.S. FDA
Midlothian, Virginia, United States
Simone Pitts, MS

National Expert, Pharmaceutical, ORA
U.S. FDA
Bridgeport, Connecticut, United States

Regulatory Presenter(s)

Brooke Higgins, MS

Senior Policy Advisor, CDER
U.S. FDA
Midlothian, Virginia, United States

Presentation Handout
Simone Pitts, MS

National Expert, Pharmaceutical, ORA
U.S. FDA
Bridgeport, Connecticut, United States

Presentation Handout

Presentations:

13:45 – 14:10 EDT

Holistic Contamination Control Strategy (CCS) for Sterile Drugs including Cell and gene Therapy Products
Presenter: Biswarup Dasgupta, MS – NA
14:10 – 14:26 EDT

Hot Topics and Regulatory Expectations in Aseptic Processing
Regulatory Presenter: Brooke K. Higgins, MS – U.S. FDA
14:26 – 14:56 EDT

Sterile Drug Hot Topics
Regulatory Presenter: Simone E. Pitts, MS – U.S. FDA
14:56 – 15:15 EDT

Live Q&A (B5)
Moderator: Douglas A. Campbell – InterPro QRA
Panelist: Biswarup Dasgupta, MS – NA
Panelist: Glenn E. Wright, MA – PDA
Regulatory Panelist: Brooke K. Higgins, MS – U.S. FDA
Regulatory Panelist: Simone E. Pitts, MS – U.S. FDA