Source: http://www.complianceonline.com/21-cfr-part-11-compliance-role-of-predicate-rules-webinar-training-700177-prdw
Timestamp: 2017-03-24 10:24:42
Document Index: 199109808

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Complying with 21CFR Part 11-Understanding the Role of Predicate Rules : Compliance Training Webinar (Online Seminar) - ComplianceOnline.com
› Complying with 21CFR Part 11-Understanding the Role of Predicate Rules
Instructor: Tony Dunbar
Product ID: 700177 Duration: 60 Min recorded version
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. Description
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.
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
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:
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.
Bringing FDA Pharmaceutical GMPs into the 21st Century Refund Policy