Validation and 21 CFR Part 11 Compliance of Computer Systems

This course is appropriate for beginner and experienced person alike. The topics will build on each other and will give you the latest trends in our heavily regulated industry and how to make it easy for yourself while still achieving data integrity.

The attendees will be given take away templates that will enable them to build a complete package to meet Data Integrity Requirements for Computerized Systems.

We have all heard of Computer Systems Validation & Data Integrity, but do you really understand what it is? Do you understand how 21 CFR 11 and Annex 11 fit into this picture? Specifically, can you answer questions on the following:

• 21 CFR Part 11 and Computer Validation: Why so many citations?
• Computer Systems Validation (CSV) and 21 CFR 11 vs Annex 11
• Data Integrity vs Computer Systems Validation
• Overview and Key Requirements of Part 11 & CSV
• How to use a Risk Based Assessment to reduce work while still achieving Compliance?
• How FDA & other Regulatory Authorities Inspect Computerized Systems for Data Integrity?