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Compliance for Computer Systems Regulated by FDA - 2017

Start Date:
Sunday, 1 October, 2017
End Date:
Sunday, 1 October, 2017 11:30am
Health & Nutrition

Overview:The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability. Why should you Attend:This Webinar will help you understand in detail the application of FDA's 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations.

Areas Covered in the Session:Validation StrategySystem Risk AssessmentGAMP 5 "V" Model21 CFR Part 11Electronic Records/Electronic Signatures (ER/ES)Security, Access, Change Control and Audit Trail Who Will Benefit:Clinical Data Managers and ScientistsAnalytical ChemistsLaboratory ManagersAutomation AnalystsManufacturing and Supply Chain Managers and AnalystsComputer System Validation Specialists Speaker Profile:Carolyn (McKillop) Troiano Carolyn Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries.

She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Contact Detail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email:


Netzealous LLC DBA - Compliance4All

Organizer Details

Conference organized by Netzealous LLC DBA - Compliance4All

Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.

Netzealous LLC DBA - Compliance4All

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