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DMD

US & China Current Good Manufacturing Practices (CGMP)
Emergo Group

Wednesday, November 29, 12:00-1:00 PM
Meeting Room A

Organizer: David Melander, Neos Discovery Capital, LLC

Session Abstract:

1) Latest trends in Current Good Manufacturing Processes (CGMP) in China;
2) CGMP in the USA and EU for Chinese manufacturers;
3) Potential for harmonizing CGMP regulations between China and the USA.

Speaker:

 

Mike FinchSherry Jia, Senior Project Engineer & Lead Auditor, Ul-CCIC Company, Ltd.

This talk will present latest trends in Current Good Manufacturing Processes (CGMP) in China and potential for harmonizing CGMP regulations between China and the USA.

Sherry has more than 20 years in the medical device industry, 10 years of the third certification bodies auditors and seminar speaker experience. She currently acts as a senior project engineer and lead auditor for CGMP, ISO 13485/ MDD/ CMDCAS/INMTERO, and presenting external seminar for CGMP, ISO13485, ISO14971 and QSR820. She has rich experience in design and development, production and quality management of medical device and is familiar with Chinese regulatory such as CGMP, registration of CFDA and international regulatory of EU, FDA.


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