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2005 U.S. FDA cGMP China Training
Program Starts at PKU
By Yuan Limei
PKU NEWS 2005--12-5
http://ennews.pku.edu.cn/news.php?s=133853215
Peking University, Beijing, Dec. 5th, 2005: Sponsored jointly by U.S. Food and Drug
Administration (FDA), International Society for Pharmaceutical Engineering (ISPE)
and Peking University, 2005 U.S. FDA cGMP China Training Program started at the
Sunshine Hall of Yingjie Communication Center today. This is the first official training
class held by FDA in China and has attracted more than 270 managers and
inspectors from pharmaceutical manufacturers and drug administrations.
Chairman of ISPE Paul Deramo, former Deputy Director of State Food and Drug
Administration (SFDA) Ren Dequan, and Vice-President of PKU Lin Jianhua were
present at the opening ceremony and delivered speeches. Deputy Director of
Compliance Office, FDA, Joseph Famulare also made a brief introduction about the
training program and expressed his appreciation for those who had contributed to its
final realization through long-distance TV system.
After the opening ceremony, Nicholas Buhay, the Deputy Director of Division of
Manufacturing & Product Quality Office of Compliance, FDA, gave the lecture on
―cGMP in the USA‖, introducing the legal principles, regulations, implementation
tools and resources of cGMP in great detail, and emphasizing the quality-test of any
drug along with the flexibility of cGMP standards. He also discussed the issue of
counterfeit drugs after a short break.
Edited By : Wang Yi
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