Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical ...

It was clear that the supply of a packaged system was seen as a completely separate activity to the validation of that system; perhaps because purchasing and validation had always been two separate ...

When you look through your inventory of computerized systems, you should be able to at least make a distinction between simple and complex systems, such as a Karl Fischer titrator and a chromatography ...

3-Day Virtual Computer System Validation (CSV) Certification Course: Comprehension of the FDA Regulations Impacting your Systems and Hands-on Practice Writing Validation Documents - ResearchAndMarkets ...

The attendee will learn how to validate systems to meet 21 CFR Part 11, and data integrity compliance. We will touch on compliance with data privacy laws, including HIPAA, GDPRs, and other privacy ...