Live -Webinar 2014 - "21 CFR Part 11 Add-On Inspections by the FDA"

DESCRIPTION
In December 2010 the 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. 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.