Source: https://www.audioeducator.com/pharma-biotech/fda-enforcement-21-cfr-11-compliance.html
Timestamp: 2018-03-24 12:01:28
Document Index: 495812605

Matched Legal Cases: ['art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11']

﻿ FDA Enforcement of 21 CFR 11 Compliance & Inspection
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Understand FDA’s View of Enforcement Under Part 11 and How You Can Prepare Your Company for an Upcoming Inspection.
Through its Part 11 inspection and enforcement program, the FDA has continued with its enforcement action. 30 warning letters were issued by the FDA related to Part 11 violations in the last three years alone. Most of the citations were related to security, integrity and availability of electronic records while some were related to software and computer systems validation.
However, typically, citations are against the predicate rules, not part 11 itself. This is very confusing and makes it difficult to determine what FDA assesses in these inspections.
To get a better insight, join expert speaker Angela Bazigos in this live webinar as she helps you get a better understanding of what 21 CFR 11 means and why and how it was implemented. She will also discuss FDA’s view of what is enforced under Part 11 inspections, and how you can prepare your company for the upcoming Part 11 inspection.
FDA’s view of 21 CFR 11 Compliance
FDA acceptance of data: Electronic and paper
Diverse nature of “source” and how to protect and preserve it
Preparing your company for a successful part 11 inspection
Clinical Data Managers and Monitors
Part 11 and Annex 11 Consultants
How to Survive an FDA Food Facility In...