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 Excel Professionals: Enhancing Productivity with Cha…
Leadership: Strategic Planning and Decision Making
2026 Form I-9 Changes & New ICE Penalties: What Every Emplo…
Human Factors Usability Studies Following ISO 62366 and FDA…
2-Hour Virtual Seminar on How to Conduct an Internal Harass…
Fostering a Culture of Respect: Eliminating Gossip, Rumour…
Bootcamp for New Managers and Supervisors: Develop These Es…
FDA Compliance for Regulated Systems using COTS, Cloud, and…
Implementing an Effective Succession Plan to Identify, Deve…
Boost Financial Analysis with Claude in Excel
ChatGPT for HR - Build HR Policy Framework and Strategy
I-9 Enforcement & Compliance: A 5-Step Plan for Employers t…
The Anti-Kickback Statute: Enforcement and Recent Updates
Wage & Hour Laws: Ensuring Compliance with the Fair Labor S…
Emotional Intelligence: Mastering the Emotions of Great Lea…
Expense Reimbursements 2026 - Proper Recordkeeping and Acco…
Unlock Employee Loyalty: Stay Interviews Will Keep Them Eng…
Construction Lending And Real Credit Administration: Evalua…
Dealing With Difficult People: At Work & In Life
Claude AI For CPAs & Finance Professionals: Best Practices …
Secrets Of The Staffing Fix - Solving The Employee Training…
Mastering the Prompt: How Every Professional Can Use AI to …
Eliminate Harmful And Unproductive Drama In The Workplace
Using Copilot to Format Legal Documents in Microsoft Word
Setting SMART Goals & Leveraging Storytelling for Reporting
Excel + AI: The Smart User's Guide to Faster, Easier Work w…
Discover how Emotional Intelligence turns AI from a technic…
Introduction to Microsoft Power BI Dashboards
Excel Spreadsheets; Develop and Validate for 21 CFR Part 11…
Major cGMP Issues: FDA Concerns in 2026
Elevate Your Workplace Wellness: 10 Critical Wellness Facto…
Maximizing Productivity with ChatGPT: AI Solutions for HR, …
Excel - Pivot Tables - The Key To Modern Data Analysis and …
Managers/Supervisors: New Role, Same Team - How to Lead Wit…
HR Auditing - New Update on Important Issues for 2026
2-Hour Virtual Seminar on In-Person Onboarding Your New Hir…
6-Hour Virtual Boot Camp on Microsoft Power BI
Outlook - Master your Mailbox - Inbox Hero Inbox Zero
Managing Toxic Employees: Strategies For Leaders To Effecti…
California Meal and Rest Breaks: What You Don't Know Can Co…