US FDA cGMP Training in China

The US Food and Drug Administration (FDA) in in collaboration with the Peking University and the International Society for Pharmaceutical Engineering (ISPE) did conduct a three day training session in Beijing, China. The intent was to educate participants from China and other Asian countries on current methods for compliance with good manufacturing practices (cGMP). Number of attendees was limited to 200. They came from pharmaceutical industry, consulting companies and from regulatory agencies in China. The training consisted of plenary lectures and interactive workshops. Sessions have been presented by a total of 11 cGMP experts including four speakers from the US FDA. Agilent Technologies was the only analytical instrument supplier contributing to the technical program.

Topics covered during the training

1. Joseph C. Famulare
   FDA Perspective on CGMP Compliance - Including ICH Updates
2. Aping Zhang
   SFDA Perspective of CGMP Compliance
3. Paul D'Eramo
   Industry Perspective of CGMP Compliance
4. Hua Bai
   API Manufacturing in China
5. Nick Buhay
   CGMPs of APIs
6. Robert Horan
   Post Approval Inspection
7. Robert Chew
   Validation
8. Ludwig Huber
   Workshop on Validation in Laboratories.
   For details, click here
9. Robert Horan
   Pre-approval Inspections
10. James Dahl
    Patent Protection
11. Erik Henrikson
    Drug Counterfeit
12. Jian Wang
    Process Analytical Technology
13. Panel Q&As
    Nick Buhay/Ludwig Huber
14. 21 CR Part 11
    Joseph Famulare and Ludwig Huber
15. Panel Q&A
    All Speaker

Speakers

• Joseph Famulare, Acting Director, Office of Compliance, FDA CDER
• Nicholas Buhay, Acting Director in FDA/CDERs Division of Manufacturing and Product Quality
• Erik Henrikson, Deputy Director, Office of Compliance, FDA CDER
• Dr. Robert C. Horan, Biotechnology Specialist, FDA
• Robert E. Chew, P.E., Vice President, Commissioning Agents, Inc
• Hua Bai, President, Zhejiang, Hisun Pharmaceutical Co., Ltd
• Paul D'Eramo, Executive Director, Quality and Compliance Worldwide, J&J
• James Dahl, Federal Criminal Investigator
• Dr. Jian Wang, Senior Consultant, Mettler Toledo AutoChem
• Aiping Zhang, Associate Professor of Pharmacy, Director of the Certification Committee for Drugs, SFDA
• Dr. Ludwig Huber, Worldwide Compliance Program Manager, Agilent Technologies and Chief Editor of Labcompliance

	Group photo with speakers and officials from the University and ISPE
330	Nick Buhay and Ludwig Huber in the Q&A Discussion Session
	Joseph Famulare explains the audience FDA's new directions for Part 11
	Yu Meng, Quality Operations Manager of Pfizer, Dalian China, translating Ludwig Huber's presentation
	Attendees could participate in a test to get the certificate. The winners have been awarded by Balwant Gewal, Vice President of ISPE Asia Pacific Operations (right)
	From left to right: Ms. Hui Zhu, Prof. Qiang Zheng, Dr. Ludwig Huber and Chen-Jie Zhuang, Agilent. Agilent not only was the only analytical instrument supplier contributing to the FDA training program, but also was one of two main sponsors.
	Caleb Ng, Senior Data System Specialist of Agilent Technologies, gave a presentation on how well designed and validated data systems can help to comply with GMP regulations and 21 CFR Part 11.
	The training ended with a panel discussion. The panel answered questions from the audience.
	Eric Henrikson, Joseph Famualre, Nicholas Buhay and Ludwig Huber at a typical Chinese lunch
	FDA's Famulare, Buhay, Doran and Ludwig Huber in the joint SINO-SFDA-US FDA cGMP /workshop