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21 CFR Part 11 Conformance for Medical Devices
Friday, 14th April, 2023
Time : 01:00 PM EST | 10:00 AM PST
Recorded Webinar
21 CFR Part 11 Conformance for Medical Devices
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Edwin Waldbusser
Short Abstract
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 all this means. A 21CFR checklist and a Test protocol form will be given as handouts
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.
The presentation will cover the following areas:
- Patient Safety
- How to Prevent Electronic Records
- How 21 CFR part 11 considers both data security and patient safety.
- The confusion over the original FDA regulation and its subsequent “selective enforcement” will be explained.
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