Event focus is risk-based approaches for FDA-regulated complex systems
BOSTON, Jan. 27, 2014 /PRNewswire/ — IVT Network (www.ivtnetwork.com), the global leader in validation training for FDA-regulated industries, announced today the agenda and speaking faculty for its 15th Annual Computer and Software Validation Conference. The large annual flagship conference is being held April 23-25, 2014 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 an excellent 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.
About IVT Network
IVT Network (www.ivtnetwork.com), an Advanstar data service, is the leading knowledge resource for validation professionals. It provides regulatory and industry guidance through peer-reviewed journals, special reports, protocols, training videos, whitepapers, conferences and more. Since 1997, the Institute of Validation Technology (IVT), publisher of the Journal of Validation Technology and the Journal of GXP Compliance, has been dedicated to expanding the global knowledge base for validation and compliance in FDA regulated industries.
About Advanstar:
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For more information contact:
Kathy Stewart
IVT Network
339-298-2117
Email
www.ivtnetwork.com