2015-04-21
The HKBIO US-FDA’s Medical Device Regulations Seminar was organized by Hong Kong Biotechnology Organization (HKBIO); sponsored by Lee’s Pha…
## April 21, 2015
The HKBIO US-FDA’s Medical Device Regulations Seminar was organized by Hong Kong Biotechnology Organization (HKBIO); sponsored by Lee’s Pharmaceutical Holdings Limited, Powder Pharmaceuticals Incorporated and Hong Kong Science and Technology Parks Corporation (HKSTP), and held in Hong Kong Science Park on April 21, 2015. . We invited Mr. Francis John Eng (ex-FDA Investigator from 1972-2014) to give a training seminar regarding US FDA’s Medical Device regulations, primarily covering 21 CFR 803 and 21 CFR 820, including the following topics:
- QSR / GMP
- CAPA
- Risk Management
- MDRs
- US FDA Inspections in China
To download the slides of the seminar, please click here ( http://www.hkbio.org.hk/html/file/FDA%20Seminar.zip ).