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.
Female to Female Hostility @Workplace: All you Need to Know
The Importance of the first 5 seconds when presenting
How to Manage the Legal Landmine of the FMLA, ADA and Worke…
Managing Difficult Employee Conversations
How to Write Effective Audit Observations: The Principles f…
Managing Toxic & Other Employees Who Have Attitude Issues
2025 EEOC & Employers: Investigating Claims of Harassment …
Leadership: Strategic Planning and Decision Making
FDA Proposes Framework to Advance Credibility of AI Models
Reduce Stress in the Workplace: Effective Ways to Handle Co…
ChatGPT and Project Management: Leveraging AI for Project M…
Leverage AI-Powered Tools for Talent Acquisition: Best Prac…
6-Hour Virtual Seminar on Learning the Highlights of Excel …
With Mandatory Paid Leave Gaining Ground Is It Time To Do A…
Form W-9 Compliance: TIN Verification, B Notices, and Avoid…
How to Give Corrective Feedback: The CARE Model - Eliminati…
Tattoos, hijabs, piercings, and pink hair: The challenges …
Stress, Change And Team Resilience Through Humor: An Intera…
Elevate Your Workplace Wellness: 10 Critical Wellness Facto…
AML Regulatory Insight for Q1 2025: Implementing recent cha…
How to Write Right for Better Business Communication
Gossip-Free: Leadership Techniques to Quell Office Chatter
Improving Employee Engagement & Retention Through Stay Inte…
Transforming Anger And Conflict Into Collaborative Problem …