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FDA's 21 CFR 11 Add-On Inspections - Recent Updates

Event Details

FDA's 21 CFR 11 Add-On Inspections - Recent Updates

Time: March 11, 2019 from 10am to 11:30am
Location: Online Event
Street: Online Event
City/Town: Fremont
Website or Map: https://www.traininng.com/web…
Phone: (510) 962-8903
Event Type: webinar
Organized By: Joseph Wilcox
Latest Activity: Feb 1

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Event Description

Overview

In December 2010 FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, it has now turned into an ongoing program with Part 11 related issues being part of most future inspections. 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.

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. This will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome.

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