Topics
- 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
- GDP related 483s and Warning letters
Who should Attend
Lead Engineers, Project Managers, Documentation Managers, Software Engineers, Contractor, Document System Control Personnel, QA, Consultants, R&D, Regulatory Affairs, Engineering & IT personnel and Manufacturing.
