This course has been updated to include the update on 21 CFR Part 11 and also electronic version of CFR part 11. Further we are ensuring to make you understand about the new FDA expectations for computer software assurance(CSA).
This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements.
Regulatory guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements.
The course will provide principles and an overview of the overall computer systems compliance.