CFR 21 Part 11 and Annex 11: How to Avoid the Audit Traps 2012 is a webinar that covers topics such as:
- Dependencies between Predicate rules and Part 11/Annex 11
- Predicate rules and Part 11/Annex 11 requirements overview
- Part 11/Annex 11 related SOPs
- Similarities and differences between Part 11 and Annex 11
- Inspection trends with examples of some recent 483s and WL
- What are auditors trained to look for during a Part 11/Annex 11 "tag along" audit
CFR 21 Part 11 and Annex 11: How to Avoid the Audit Traps 2012 brings together:
- Regulatory, QA/QC Department
- Healthcare Industry
- IT and Software Quality Assurance
- Engineering, Manufacturing and Manufacturing Science
- Project management and Validation
