Source: https://www.edupliance.com/webinar/fda%E2%80%99s-21-cfr-part-11-add-on-inspections
Timestamp: 2019-11-13 04:47:11
Document Index: 621639306

Matched Legal Cases: ['art 11', 'art 11', 'art 11', 'art11', 'art 11', 'art 11', 'art 11', 'art 11']

21 CFR Part 11 - FDA's Guidance for Compliance of Computer Systems and Electronic Records and Electronic Signatures webinar
Home > Webinar > FDA's 21 CFR Part 11 Add-on Inspections
FDA began a project to better understand the industry’s adherence (or lack thereof) to 21 CFR Part 11. This involves the add on’ surveillance inspections of the sponsors’ computer systems during the course of the FDA’s regular inspections.
Join this session by expert speaker Angela Bazigos, where she will enable you to determine whether your company is subject to the most common violations.
How important is risk-based Part11 compliance?
This presentation will cover the scope, status, and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. At the beginning of the initiative, FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003. In the meantime, FDA officials reported about key findings. For example, George Smith who heads up FDA's Part 11 working group gave an update with examples of violations.