ChemWerth 2009 cGMP Seminar a Great Success
ChemWerth sponsored a training seminar for its Chinese Manufacturers on December 11-12, 2009 entitled “Systematic Approach to cGMP Compliance” in Nanjing, China. This was the 8th seminar sponsored by ChemWerth since 2000.
Presentation topics included:
- Regulatory and Industry Trends (Dr. Yaping Shen, CW-SHA General Manager),
- Impurity and ROS Issues (Judy Yu, CW-SHA Senior Associate of New Product Development),
- Systematic Approach to cGMP Compliance (Jeff Hangartner, CW-SHA Associate Director of Regulatory and Compliance, former FDA investigator),
- Data Integrity (Guest Speaker),
- QC Lab Inspections (Sunny Chen, CW-SHA Senior Associate of Regulatory and Compliance),
- Corrective Action and Preventative Action (CAPA) in cGMP (Dr. Tang Peng, CW Director of Regulatory and Compliance), and
- Microbiological Laboratory cGMP Management (Paolo Liu, CW-SHA Senior Associate of Regulatory and Compliance).
More than 80 quality and compliance managers from more than 20 pharmaceutical companies attended the seminar. Audience members reacted positively to the seminar, with 100% rating their overall impression of the seminar as ‘Excellent’ or ‘Good;’ trainees appreciated that the presenters illustrated their points with actual examples and provided solutions to problems. 85% gave the logistic arrangement of the seminar ‘Excellent’ or ‘Good’ ratings as well. Trainees felt that on-site training would be the most effective, though expensive, method for CW to help factories improve cGMP compliance levels, followed by receiving updates of FDA cGMP-related news.
For next year’s seminar, factories expressed interest in hearing more about specific topics in greater depth, such as practical examples related to cGMP, common deficiencies in FDA inspections and their solutions, quality risk management, and cleaning validation. The ChemWerth 2010 cGMP Seminar is tentatively scheduled for November 2010 in Shanghai.
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