Online Live Overview This Virtual course includes the new revised EU GMP Annex 11, and an update on 21 CFR Part 11. This two-day fundamental course* introduces participants to regulatory requirements for computerized...
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...
This GAMP Data Integrity 21 CFR Part 11 Training Course will cover data integrity, electronic records and signatures, and the compliant operation of....
This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried....
This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried....
