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.
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
Instructor Profile
Tony Dunbar, M.Sc., has over 25 years experience in Quality Management with Warner-Lambert/Pfizer and currently with PENSA as their Senior Compliance Consulting Expert. PENSA (www.gmps.com) provide compliance services and validation/compliance software to the Life Science Industries. In his role at PENSA, Tony has performed, on behalf of a number of industry-leading clients, assessments and validation of various computer systems against Part 11 requirements. These systems have included ERP, LIMS, HPLCs, etc. Tony has also been a presenter of GMP topics and Part 11 at industry group seminars.
