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.
Navigating FDA Inspections: From SOP to 483
2-Hour Virtual Seminar on DeepSeek R1 for Business and Mark…
The Anti-Kickback Statute: Enforcement and Recent Updates
Risk Analysis in the Medical Device Design Process
2025 EEOC & Employers: Investigating Claims of Harassment …
How To Get Control of Your Day, Life & Career - Time Manage…
AI Across the Business: Practical Use Cases for Founders an…
Introduction to Microsoft Power BI Dashboards
Writing Effective 483 and Warning Letter Responses
6-Hour Virtual Seminar on Learning the Highlights of Excel …
FDA Recommendations for Artificial Intelligence/Machine Lea…
Female to Female Hostility @Workplace: All you Need to Know
Leadership: Strategic Planning and Decision Making
Writing Techniques for Auditors and Risk Management Profess…
Language is Code - Intro to AI - Generative AI - ChatGPT an…
Gossip-Free: Leadership Techniques to Quell Office Chatter
Do's and Don'ts of Giving Effective Feedback for Performanc…
4-Hour Virtual Seminar on Audit Proofing your Payroll Opera…
Retention Starts Here: Stop Losing Your Critical Talent and…
Do's and Don'ts of Documenting Employee Behaviour, Performa…
Practice Safe Stress ™: Preventing Burnout While Building R…
Impact Assessments For Supplier Change Notices
Cleanroom, Microbiology and Sterility Assurance Practices f…
Understanding EBITDA – Definition, Formula & Calculation
Thriving in a Hybrid Workplace: Keys to Leadership and Team…
2-Hour Virtual Seminar on DeepSeek vs ChatGPT AI for CPAs a…
Construction Lending And Real Credit Administration: Evalua…
How the OBBB Act will Impact Immigration Enforcement! Preve…
2-Hour Virtual Seminar on Outlook - Timesaving Tips and Tri…
Leadership Upskilling: Don’t Just Manage; Lead with Influen…
H-1B Visa Updates and Employer Strategies for 2026
Aligning Your HR Strategy with Your Business Strategy: A Ro…
HIPAA 2025 – Major Changes, Latest Rulings & Guidance
Excel Power Skills: Master Functions, Formulas, and Macros …