21 CFR Part 11 Conformance for Medical Devices
Learn what 21 CFR Part 11 requires for electronic records and signatures, how it differs from IT security, and how to validate open, closed and hybrid systems.
Speaker
Edwin Waldbusser
Medical device consultant · 20 years in medical device development
Overview
Medical device companies want electronic records for efficiency, while FDA wants to keep those records from being compromised in ways that could harm patients. 21 CFR Part 11 addresses both data security and patient safety.
This 90-minute webinar explains what Part 11 is, why it matters, and how conformance differs from simply having good IT security. You'll learn the procedures for controlling electronic records and signatures described in FDA guidance, and the technical and procedural requirements for Part 11 validation.
The session also explains the origin of the regulation, the confusion around FDA's "selective enforcement", and how open, closed and hybrid paper-electronic systems differ, along with risk analysis.
Why attend: Many companies hesitate to move to electronic records for fear of weakening their quality system and receiving 483s. Much of that fear comes from confusion about how FDA enforces Part 11. This session clears it up for engineering, QA, IT and management staff at medical device companies.
What’s covered
- Origin of the regulation and changes in interpretation
- Selective enforcement explained
- Electronic records
- Electronic signatures
- Part 11 vs general 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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