US regulations on computers in drug manufacture first appeared in 1978, followed by the EU in 1992. Understanding the different motives for regulations, modifications, and approaches could help better comprehend current US and EU regulations, especially...
The EC has announced a new revision of EU GMP Annex 11 Computerised Systems. There are also associated changes to EU GMP Chapter 4 Documentation. Annex 11 has been revised in response to the increased use of computerised...
A detailed and comprehensive GAMP interpretation of the new revised EU GMP Annex 11 has been produced by a core GAMP CoP Task Team of industry experts, and reviewed by the GAMP CoP Council and members of GAMP Regional...
This online course will give participants a practical introduction to the 21 CFR Part 11 regulations, which affects many aspects of computerized systems in the pharmaceutical industry. The course will present an overview...
This two or three-day fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry....
This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried....
