Connecting Pharmaceutical Knowledge
ISPE Thailand: Computerized Systems Validation (CSV): GAMP 5 approach in pharmaceutical industry
Date
13th- 14th December 2023
Venue
Ambassador Hotel, Bangkok, Thailand
Details
Currently, the pharmaceutical and biological industries have implemented computerized systems in various production processes from R&D to release to the market.
To ensure that those computerized systems are reliable and efficient, Computerized Systems Validation (CSV) according to the Good Automation Manufacturing Practice (GAMP 5) plays a huge role in the pharmaceutical manufacturing industry. Entrepreneurs in the pharmaceutical manufacturing industry must understand how to treat these computer-based systems.
At this seminar, attendees will learn how to perform Computerized Systems Validation (CSV) according to the Good Automation Manufacturing Practice (GAMP 5) based on PIC/S & European GMP requirements on computer-based systems which are currently being reviewed and FDA 21 CFR PART 11.