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Managing Validation Life Cycle Sans Paper: A Working Model
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Track:
Validation (VA)
Day & Time:
June 17, 10:30AM - 12:00PM
Room Number:
154AB
Level:
Intermediate
Session Title:
Session # 442- Managing Validation Life Cycle Sans Paper: A Working Model
Session Chair(s):
Nagesh J Nama, MS
President
ValiMation, Inc., United States
Session Description:
This session demonstrates that paperless validation is not an oxymoron. A paperless validation platform leverages Web 2.0 technology to change the current paradigm. This platform can increase efficiencies while saving millions of dollars for the FDA-regulated industry.
Objective:
Discuss the value of a paperless system as opposed to paper or "paper on glass"; Explain how a paperless system places priority on managing good engineering practices (GEP) and processes; Explain how the new paperless platform can save cost while increasing efficiencies; Describe opportunities to increase collaboration in paperless validation.
Presentation(s) & Speaker(s):
Paperless Validation: A Real World Case Study
Jim McElroy
Technical Process Leader, Contract
Novartis Pharmaceuticals Corporation, United States
Building a Paperless Validation Platform Leveraging Web 2.0 Technologies
Nagesh J Nama, MS
President
ValiMation, Inc., United States
Part 11 Compliance on the SharePoint Content Management and Collaboration Platform
Les Jordan
Chief Technology Strategist, Life Sciences
Microsoft Corporation, United States
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