CGMP training in the use of the U.S. FDA 21 CFR part 11 compliance, coupled with the ISO 14971 risk management model

Date : 11th May 2016 to 11th May 2016

Place : United States, New hyde park

Website :https://complianceglobal.us/product/700348/WalterBaker/export-risks-and-risk-mitigation-techniques/1

Contact Person:Compliance Global Inc.

Description:

CGMP training in the use of the U.S. FDA’s 21 CFR part 11 compliance, coupled with the ISO 14971 risk management model

CGMP training in the use of the U.S. FDA 21 CFR part 11 compliance, coupled with the ISO 14971 risk management model will be held in New hyde park,United States on date 2016-05-11

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Deadline for abstracts/proposals : 11th May 2016

Keynote Speakers : John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 33 years' experience in U.S. FDA regulated industries, 19 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment in

Conference Highlights :Overview: The verification and validation of medical industry software used in CGMP compliance records and defined under 21 CFR 11, “Electronic Records / Electronic Signatures” is coming under increased scrutiny by the U.S. FDA. This webinar will address the use of the U.S. FDA’s 21 CFR part 11 compliance, and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Risk Management models, and their real-world implementation. A field-tested Part 11 S

Venue :Compliance Global Inc., 2754 80th Avenue, New Hyde Park, NY 11040, United States

Check the event website for more details.