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IVT Network Previews 15th Annual Computer and Software Validation Conference

February 2, 2014

IVT Network, a company focused on validation training for FDA- regulated industries, announced the agenda and speaking faculty for its 15th Annual Computer and Software Validation Conference.

According to a release, the large annual flagship conference is being held April 23-25, at the Hyatt La Jolla in San Diego, CA.

Designed for managers, directors and vice presidents in the FDA- regulated industries with responsibilities for IT, Quality, Validation, Engineering and Project Management, this year's conference focuses on risk-based approaches for FDA-regulated complex systems. The agenda includes 35 educational sessions, including presentations on:

-Mastering cloud computing

-Validating mobile devices

-Identifying and mitigating risk

-Overcoming regulatory challenges

-Comparing key elements of 21 CFR Part 11 vs. Annex 11

-Enhancing the QA/IT relationship

-Navigating CSV in a consent decree environment

-Managing quality agreements between software vendors and end users

-Ensuring data integrity and mitigating data corruption

The 15th Annual Computer and Software Validation Conference features industry perspectives from speaking faculty, including: Alkermes plc, Allergan, BBraun, Bio-Rad Laboratories, Boston Scientific, Cochlear Limited, Covance, Genoptix, McNeil Consumer Healthcare, a Johnson & Johnson Company, Medtronic, Novartis, Pfizer, Philips Healthcare and Stellartech Research. Dr. Krishna Ghosh, Compliance Officer, CDER/FDA has been invited to give the FDA regulatory address on Regulatory Challenges of Cloud Implementation and Data Integrity.

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