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FDA Compliance

Webinar: 21 CFR Part 11 -- How to Prepare for and Host an FDA Inspection

Wednesday, Aug. 24, 2011

Published: Wednesday, August 10, 2011 - 12:07

(Compliance2go: Houston) -- More organizations are striving to “go green” and develop sustainable strategies, many of which involve using computer- and cloud-based technologies. When it comes to electronic signatures and electronic records, the Code of Federal Regulations Title 21 of the Food and Drug Administration (FDA 21 CFR) Part 11—“Electronic records; electronic signatures” regulates the technology and will be increasingly a part of the scope of FDA inspections.

The hour-long webinar, “CFR Part 11: How to Successfully Prepare for and Host an FDA Inspection,” which takes place Wednesday, Aug. 24, 2011, will provide a quick overview of the requirements of Part 11, and a detailed description of how to prepare for and handle an FDA inspection when Part 11 is in the scope of the inspection.

Having the ability to access and approve records from any location around the world is more critical than ever, and more electronic records will be needed in global organizations. For both electronic signatures and electronic records, these organizations must comply with FDA 21 CFR Part 11.

Attendees will receive a copy of FDA 21 CFR Part 11, a sample internal/external audit/inspection checklist based on the regulations, and answers to more than 30 commonly asked questions about FDA inspections.

Register for the event here.

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Compliance2go

Compliance2go offers consulting, webinars, virtual seminars, and on-site training in the biotechnology, health care, medical device, pharmaceutical industries. Compliance2go staff makes a committed effort to bring the best and the ever changing and important laws available to those who needs to be educated on this regard. This is done by hosting cost effective and informative webinars, web alerts and also holding discussion forums where you can discuss on the nature, existence, and relevance of various laws. This will also help you to do networking with various professionals and give a new dimension to your business.