Loading…
Attending this event?
Back To Schedule
Tuesday, June 18 • 4:30pm - 5:30pm
#289: Post-COVID cGMP Inspections by Global Regulatory Authorities

Sign up or log in to save this to your schedule, view media, leave feedback and see who's attending!

Tweet Share
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-620-L04-P; CME 1.00; RN 1.00

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 Objectives

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.

Chair

Lan Mu, PhD, RAC

Speaker

Panelist
Celeste Frankenfeld Lamm, PhD

Drug GMP Inspections In Post-COVID Era: Challenges and Solutions
Chiang Syin, PhD

Anvisa Update
Erica Franca Costa, RPh

POST-COVID GMP Inspections of Bio-Thera by ANVISA, EMA, FDA, and NMPA
Lan Mu, PhD, RAC


Speakers
avatar for Lan Mu

Lan Mu

Senior Vice President, Bio-Thera Solutions, United States
Dr. Lan Mu has over 25 years of experience in drug discovery, development, and global registration in various therapeutic areas. She was a principal research investigator at Sanofi prior to earning the Regulatory Affairs Certification (RAC). Subsequently, she held roles of increasing... Read More →
EF

Erica Franca Costa

Health Regulation Specialist, ANVISA, Brazil
Pharmacist, Health Regulation Specialist, Senior GMP Inspector. She has been a member of the Brazilian National Health Surveillance Agency (ANVISA) since 2005, carrying out, among other activities, BPF inspections, medicine and cosmetic products registration, regulatory convergence... Read More →
avatar for Celeste Frankenfeld Lamm

Celeste Frankenfeld Lamm

Senior Director, Global Regulatory Affairs – CMC, Merck Sharp & Dohme LLC , United States
Celeste Frankenfeld Lamm, Ph.D., is currently a Director of Global Regulatory Affairs – CMC at Merck & Co, Inc. with 16 years of industry experience. In this capacity she is responsible for regulatory strategy, engagement with regulatory authorities, and preparation of clinical... Read More →
CS

Chiang Syin

President, Meadows Biosolutions LLC, United States
Dr. Chiang Syin founded Meadows Biosolutions in 2021 and serves as its President. He retired from FDA in 2017 after 29 years of services including CBER, CDER and FDA China Office. He later joined WuXi Biologics as Chief Quality Office from 2018 to 2021 overseeing its Quality Department... Read More →

Tuesday June 18, 2024 4:30pm - 5:30pm PDT
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  10: RegCMC-Product Quality, Forum