Theme: facilitating Internationalization of China Pharmaceutical Industry
Date: 26-29 October 2010
Venue:China National Conference Center, Beijing
Introduction:
To further facilitating Internationalization of China Pharmaceutical Industry and understand more about WHO, new GMP regulation in China and Europe & USA, ISPE will cooperate with CCPIE again in 2010 to hold this conference.
Contents
Keynote:
China new GMP by official from Department of Drug & Inspection
Facility Inspection by FDA official
Risk MaPP (Risk-Based Manufacturing of Pharmaceutical Products) by ISPE expert
7 Session Topics:
A. Cleaning Validation
B.Solid Dosage Forms
C.PQLI
D.Technology Transfer from R&D to Production
E.Commissioning and Qualification
F.Sterile Drug Manufacture
G.Computer System Compliance
Networking Dinner on 27 October
Facility Tour on 29 October
Organizers
ISPE - 国际制药工程协会
(International Society for Pharmaceutical Engineering)
Core Purpose: To lead global change and innovation in pharmaceutical technology and processes.
Vision: The Society will revitalize global public health through the support of scientific innovation in the development and manufacture of affordable medicines.
Activities: ISPE China office was set up in April, 2008 and supports ISPE China members via translation of technical guidelines, organizing training, conference, etc.
Introduction: Founded in 1980, ISPE (International Society for Pharmaceutical Engineering) is the world’s leading not-for-profit, neutral, not-lobbying global professional society, providing members with opportunities to develop technical knowledge, exchange practical experience, and collaborate with global regulatory agencies and industry leaders.
ISPE connects pharmaceutical science and manufacturing professionals from more than 90 countries, and provides opportunities for networking, education, and access to industry and regulatory resources. Our Members form a diverse group: industry professionals from pharmaceutical, biotechnology, and medical device companies as well as suppliers of equipment and services, regulatory authority personnel, academia, and students.
For more information, please visit: www.ispe.org.cn
CCPIE - 中国医药国际交流中心
(China Center for Pharmaceutical International Exchange of SFDA)
CCPIE: China Center for Pharmaceutical International Exchange
The affiliated organization of State Food and Drug of Administration of China
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