21 CFR Part 11 - Compliance for Electronic Records and Signatures
Learn what 21 CFR Part 11 requires for electronic records and signatures, how selective enforcement works, and how to validate open, closed and hybrid systems.
Speaker
Edwin Waldbusser
Medical device consultant · 20 years in medical device development
Overview
FDA-regulated companies want electronic records for cost and efficiency, while the FDA wants to make sure those records cannot be compromised in ways that could harm patients. 21 CFR Part 11 addresses both data security and patient safety.
This 60-minute 21 CFR Part 11 compliance webinar explains what the regulation is, why it matters, and how Part 11 conformance differs from simply having good IT security. You'll learn the procedures for controlling electronic records and signatures described in FDA guidance.
The session also covers the FDA's validation requirements, which have both technical and procedural parts, and explains open, closed and hybrid paper-and-electronic systems.
Why attend: Much of the worry around Part 11 comes from confusion. The FDA first published a strict version of the rule, then, after industry objected that no one would move to electronic records, chose to "selectively enforce" parts of it rather than rewrite it. This webinar explains what that means in practice. It is aimed at engineering, QA, IT and management staff in FDA-regulated companies.
What’s covered
- Origin of the regulation and changes in interpretation
- Electronic records
- Electronic signatures
- Data security
- Open, closed and hybrid systems
- Validation methods
- Risk analysis
Who should attend
What you get
About the speaker
Edwin Waldbusser, is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.
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