This Webinar will explain what 21 CFR Part 11 is, why it is essential to FDA-regulated companies, and how its conformance to Part 11 differs from having good IT security.
Procedures for controlling electronic signatures and electronic records as described in the FDA Guidance will be explained.
FDA-regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants to prevent electronic records from being compromised with possible resulting harm to the patient. FDA has set up regulations that address both data security and patient safety. We will show how 21 CFR part 11 considers both.
The confusion over the original FDA regulation and its subsequent "selective enforcement" will be explained. FDA requirements for 21CFR Part 11 validation will be presented. the requirements are composed of technical and procedural aspects. open, closed, and hybrid (paper and electronic) systems will be explained.
Part of this fear originates from confusion. The FDA originally published a rather severe 21 CFR Part 11. After industry complaints, the FDA acknowledged that the regulation, as written, would result in nobody attempting to convert to electronic records. But, instead of rewriting the regulation, the FDA said it would "selectively enforce" sections of the regulation.
This webinar will explain what all this means. A 21CFR checklist and a Test protocol form will be given as handouts.
Part of this fear originates from confusion. The FDA originally published a rather severe 21 CFR Part 11. After industry complaints, the FDA acknowledged that the regulation, as written, would result in nobody attempting to convert to electronic records. But, instead of rewriting the regulation, the FDA said it would "selectively enforce" sections of the regulation.
This webinar will explain what all this means. A 21CFR checklist and a Test protocol form will be given as handouts.
Edwin Waldbusser
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.
AI for Project Managers: Smarter Planning Reporting and Com…
Mastering Performance Management: Strategies for Continuous…
ChatGPT for Innovative Business Advisory Services for Accou…
Female to Female Hostility @Workplace: All you Need to Know
Latest Trends in Human Error Reduction in GMP Manufacturing
Bootcamp for New Managers and Supervisors: Develop These Es…
Analytical Method Validation Under Good Laboratory Practice…
2-Hour Virtual Seminar on The Complexity and Interplay Amon…
2-Hour Virtual Seminar on How to Conduct an Internal Harass…
Data Integrity and Privacy - Compliance with 21 CFR Part 11…
Do's and Don'ts of Documenting Employee Behaviour, Performa…
Fostering a Culture of Respect: Eliminating Gossip, Rumour…
The Perfect Storm Coming to Healthcare: Value Based Care Me…
Payroll Record Keeping: How to Thin Out File Cabinets and Q…
Medical Device Cybersecurity Following FDA’s 2026 Premarket…
Construction Lending And Real Credit Administration: Evalua…
HIPAA Compliance in 2026 — Practical Strategies for Breach …
Moving From an Operational Manager to a Strategic Leader
Launch Your Career: The Ultimate Guide for Emerging Profess…
Dealing With Difficult People: At Work & In Life
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Discover how Emotional Intelligence turns AI from a technic…
The 6 Most Common Problems in FDA Software Validation and V…
High-Impact Performance Management: Tools, Tactics & Coachi…
The 60 Minutes Introduction to DAX
Empowering Conflict Resolution: Letting Go to Gain Control
AI Across the Business: Practical Use Cases for Founders an…
Faster, Better Talent Acquisition: Leveraging AI & ChatGPT …
The Anti-Kickback Statute: Enforcement and Recent Updates
Goal Mastery: From Resolutions to Results in 2026
Your AI Advantage: How HR Professionals Can Use Claude to S…
Human Error Reduction Techniques for Floor Supervisors
Validation of FDA-Regulated Medical Device and SaMD Product…
Human Factors Usability Studies Following ISO 62366 and FDA…