FDA Part 11 and EU Annex 11 Discussion

FDA's renewed emphasis on enforcing 21 CFR Part 11 - along with the EU's re-issuance of Annex 11 - is the subject of my new webinar on Tuesday, October 12th.

If you're based in the US, clearly Part 11 is of concern, but if you're based outside the US yet sell products in the US, Part 11 needs to be on your radar.  The same holds true if you're based in the US and sell products in the EU - you'll be complying with Annex 11 as well.

What will this mean for you?

FDA has begun extending routine inspections to evaluate compliance with Part 11 requirements to ensure companies are maintaining electronic records and document controls with accuracy, integrity, and authenticity.  There are many questions about this effort, and worries that this presages a return to the days of "validate everything."

The EU recently issued its revised Annex 11 to the EU GMPs on electronic data integrity, and firms in the US are woefully unprepared.

During the program, I'll walk you through the scope of the new Part 11 enforcement program and compare it to Annex 11, offer insights into what inspectors are looking for, and provide suggestions on how to prepare your company for the upcoming inspections.

Overall agenda:

• New requirements in Annex 11 and FDA's reinterpretation of Part 11
• How to use risk-based decision-making to support your IT compliance plans
• Steps to take advantage of vendor efforts, documentation, and services
• FDA Part 11 citations associated with e-record integrity and data quality
• Cost-effective strategy for complying with Part 11 and Annex 11

Attendees will receive bonus documents, a trial subscription to my FDA client newsletter along with some other freebie downloads.  If you'd like to register, please visit the ExpertBriefings website at http://www.ExpertBriefings.com.

Hope to hear from you on the call, and please let me know if you've signed up - drop me a line!

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