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A Simpler Approach to Implementing or Validating CGMPs to 21 CFR 11, Electronic Records, Signatures

24 August 2011, Wilmington, United States


Introduction
The verification and validation of electronic records and electronic signature software is coming under increased scrutiny by the U.S. FDA.

This webinar will address the use of FDA Guidance's, GAMP, 21 CFR Part 11, "Electronic Records" / "Electronic Signatures", and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Product Risk Management models, to structure, run, and document acceptable cGMP Part 11 software validations. The FDA and other regulatory agencies have stated that software validation can realistically only be accomplished effectively if "risk-based". How can this be accomplished in the "real world".

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Venue
online training webinar

online training webinar, 1000 N West Street, Suite 1200, Wilmington, 19801, United States

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Organised by
globalcompliancepanel
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