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 add on’ surveillance inspections of the sponsors’ computer systems during the course of the FDA’s regular inspections.
This session by expert speaker Angela Bazigos 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 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 webinar 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.
Who Should Attend?
Angela Bazigos is the CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers & Public Health Services companies. Positions include Chief Compliance Officer at Morf Media, Director of QA,...
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