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21 CFR Part 11 Compliance

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Course Description:

         FDA regulated companies wants transition to electronic records for economy and efficiency. Because of its concern for patient safety, FDA 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

        This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records will be explained.

Hear from our Speaker

Why should you Attend?

         Companies want to transition to electronic records but are afraid of compromising their quality system and receiving 483's at their next inspection. Part of this fear originates from confusion. 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, FDA said it would "selectively enforce" sections of the regulation. This webinar will explain what this means.

Areas Covered:

In this webinar you will learn
  • Company certification
  • Records covered
  • Audit trails
  • Open/closed system access rules
  • Electronic signatures
  • Training requirements

Who will benefit?

This webcast will be of a valuable assistance to the below audience.

  • Engineering Personnel
  • Quality Assurance
  • Information Technology
  • Management
  • Medical Device Companies

Registration Options

Avail 12 months unlimited access for a single user.

Material shipped within 15 days post webinar completion & get life time access for unlimited participants.


FDA Guidance, Electronic Records, 483's, 21 CFR Part 11, FDA regulated companies, IT security, Electronic Signatures and Electronic Records, Data Security and Patient Safety

Speaker Details

Edwin Waldbusser

Edwin Waldbusser

Medical Device Consultant

Ed 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.

Refund Policy

Participants/Registrants for our live events, may cancel up to 72 hours prior to the start of the live session and ComplyArena will issue a letter of credit to be used towards any of ComplyArena's future events. The letter of credit will be valid for 12 months.

ComplyArena will process refund in cases where the event has been cancelled and is not rescheduled within 90 days from the original scheduled date of the webinar. In case if a live webinar is cancelled, participants/registrants may choose between recorded version of the course or a refund. Refunds will not be processed to participants who do not show up for the webinar. A webinar may be cancelled due to unavoidable circumstances, participants will be notified 24 hours before the scheduled start of the event. Contact us via email: or call +1-888-222-5917 (Toll Free).