FDA Compliance 2012 - CFR 21 Part 11 and Annex 11: How to Avoid the Audit Traps

This 90-minute webinar on Part 11/Annex 11 audit and enforcement will tell you what the auditors are trained to look for during a Part 11/Annex 11 “tag along” audit.

Regulatory compliance requirements for CFR 21 Part 11/Annex 11 (also known as ERES) have undergone several revisions since its inception during the late 1990s. While the agencies have endeared themselves to the industry by adopting a flexible audit approach for ERES, they are increasingly requiring companies to comply with the regulations.

Areas Covered:
- Predicate rules and Part 11/Annex 11 requirements overview
- Dependencies between Predicate rules and Part 11/Annex 11
- Similarities and differences between Part 11 and Annex 11
- Part 11/Annex 11 related SOPs
- What are auditors trained to look for during a Part 11/Annex 11 "tag along" audit
- Inspection trends with examples of some recent 483s and WL