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Post-COVID cGMP Inspections by Global Regulatory Authorities
Session Chair(s)
Lan Mu, PhD, RAC
Senior Vice President
Bio-Thera Solutions, United States
Unfold real-world post-COVID inspections at global pharmaceutical manufacturing facilities, gaining insights into successes and disappointments within them. Appreciate perspectives on post-COVID inspections from FDA, EMA, Anvisa, and NMPA inspectors.
Learning Objective : Recognize key advances and innovations that regulatory authorities and manufacturing facilities have adopted post-COVID in cGMP inspections;. Identify ongoing challenges that regulatory authorities and manufacturing facilities face in maintaining compliance and ensuring product quality in the post-COVID landscape and their implications in future pharmaceutical developments.
Speaker(s)
Drug GMP Inspections In Post-COVID Era: Challenges and Solutions
Chiang Syin, PhD
Meadows Biosolutions LLC, United States
President
Post-COVID cGMP Inspections: Anvisa Experience
Erica Franca Costa, RPh
ANVISA, Brazil
Health Regulation Specialist
POST-COVID GMP Inspections of Bio-Thera by ANVISA, EMA, FDA, and NMPA
Lan Mu, PhD, RAC
Bio-Thera Solutions, United States
Senior Vice President
Panelist
Celeste Frankenfeld Lamm, PhD
Merck Sharp & Dohme LLC , United States
Senior Director, Global Regulatory Affairs – CMC
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