Annex 11: Computerised Systems

Online Learning Courses
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...
Online Learning Courses
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...
Training
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...
Training
This GAMP Data Integrity 21 CFR Part 11 Classroom Training Course will cover data integrity, electronic records and signatures, and the compliant....
Training
This two or three-day fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry....
Training
This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried,....
Training
This classroom course will be an explanation of the GAMP approach to 21 CFR Part 11 compliance, as well as compliance with other international....