FDA’s 21 CFR Part 11 Add-on Inspections
This Webinar is Available in Recording
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Faculty: John E. Lincoln
Time & Location
This Webinar is Available in Recording
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About the event
Description
The verification and validation of cGMP software is coming under increased scrutiny by the U.S. FDA. This webinar will address the use of U.S FDA Guidance, GAMP, 21 CFR 11, Electronic Records / Signatures, and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Risk Management models, and their real-world implementation. Just what are "add-on inspections".
Software has become pervasive in medical product manufacturing documentation and cGMP compliance actions, and in the controlling, running and monitoring of medical product processes, whether they be in the pharmaceutical, medical device, biologics or dietary supplements industries. Software is being developed for routing, managing, approving and signing all manner of cGMP documentation, maintenance of "controlled documents" as well as their update and archiving. The U.S. FDA has in effect eliminated it's "selective enforcement" policy / "add-on" inspections, and is looking for proper implementation of the control of electronic…