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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
President, Meadows Biosolutions LLC, United States
Post-COVID cGMP Inspections: Anvisa Experience
Health Regulation Specialist, ANVISA, Brazil
POST-COVID GMP Inspections of Bio-Thera by ANVISA, EMA, FDA, and NMPA
Senior Vice President, Bio-Thera Solutions, United States
Panelist
Senior Director, Quality, and Global Regulatory Affairs – CMC, Merck & Co., Inc., United States
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