21 CFR Part 11 Conformance for Medical Devices
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.
- Explain what 21 CFR Part 11 is and why it matters
- Distinguish Part 11 conformance from general IT security
- Apply FDA procedures for controlling electronic records and signatures
- Describe FDA's selective enforcement approach
- Classify open, closed and hybrid systems
- Plan Part 11 validation with risk analysis
- 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
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.
- Engineering personnel
- QA
- IT
- Management
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.
Upcoming Webinars
By William Mack Copeland
Date: Nov. 6, 2026
By Carolyn Troiano
Date: Nov. 6, 2026
By Edwin Waldbusser
Date: Nov. 9, 2026
By Dev Strischek
Date: Nov. 9, 2026
By Cathy Horwitz
Date: Nov. 10, 2026
By Paul Pelletier
Date: Nov. 10, 2026
By Lesley Crook
Date: Nov. 13, 2026
By Dr. Susan Strauss
Date: Nov. 16, 2026
By Allen Evitts
Date: Nov. 17, 2026
By Dr. Bill Trombetta
Date: Nov. 17, 2026
By David Nettleton
Date: Nov. 17, 2026
By Bruce Lee
Date: Nov. 17, 2026
By Dr. Susan Strauss
Date: Nov. 18, 2026
By Mike Thomas
Date: Nov. 18, 2026
By Donna K Olheiser
Date: Nov. 19, 2026
By Charles H. Paul
Date: Nov. 19, 2026
By Diane L. Dee
Date: Nov. 19, 2026
By Abdelrahman Abdou
Date: Nov. 19, 2026
By Richard E Cascarino
Date: Nov. 20, 2026
By Edwin Waldbusser
Date: Nov. 23, 2026
By Meredith Crabtree
Date: Nov. 24, 2026
By Pete Tosh
Recorded Session
By Bruce Lee
Recorded Session
By Don Phin
Recorded Session
By Dr. Susan Strauss
Recorded Session
By Margie Faulk
Recorded Session
By Carolyn Troiano
Recorded Session
By Kelly Thomas
Recorded Session
By Rachelle D Souza
Recorded Session
By Marcia Zidle
Recorded Session
By Beverly Beuermann-King
Recorded Session
By Margie Faulk
DOL Reverses Course on Independent Contractor Rule for 2026! How Will Employers Adapt to the Change?
Recorded Session
By Mike Thomas
Recorded Session
By Marcia Zidle
Recorded Session
By Ritu Arora
Recorded Session
By Diane L. Dee
Recorded Session
By Dr. Susan Strauss
Recorded Session
By Diane L. Dee
Recorded Session
By Beverly Beuermann-King
Recorded Session
By Charles H. Paul
Recorded Session
By Marcia Zidle
Recorded Session
By Audrey Halpern
Recorded Session
