AN overview of the Part 11 regulation, with special emphasis on the key role played by the applicable predicate rules as the starting point for any Part 11 compliance assessment. In spite of the FDA’s clarification regarding the scope of electronic records subject to Part 11 as expressed in the Sep 2003 Guidance for Industry, much discussion and debate still surround the topic.
Why Should You Attend:
Many individuals still seem to miss the key fact that Part 11 only applies to records called for by predicate rule, maintained in electronic form and used in that form for regulated activities. This presentation will give a general overview of the Part 11 regulation itself, with special emphasis on the key role played by the applicable predicate rules as the starting point for any Part 11 compliance assessment. This will be illustrated by practical examples from the pharmaceutical and medical device industries.Areas Covered in the seminar:
- Part 11: Brief history and background
- Did GMPs change with Part 11?
- Validation and Part 11
- What is a predicate rule?
- Examples of predicate rule records
- Examples of predicate rule signatures
- Risk based approach to Part 11
- Future of Part 11
Who Will Benefit:
This seminar will provide valuable assistance to all regulated companies subject to FDA 21 CFR Part 11, including companies in the Pharmaceutical, Medical Device, Diagnostic and Biologics fields. The employees who will benefit include:- Validation specialists
- QA managers and personnel
- Information Technology managers and personnel
- Regulatory affairs
- Consultants
- Quality system auditors
Course Provider
Tony Dunbar,
