*Titles and speakers are subject to change
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Wednesday June 13, 2012
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Session
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Topic
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Speaker
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Company
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Time
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REGISTRATION
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Conference Opening
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Rajesh Malathker
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Johnson & Johnson
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Update from the Global Bioanalysis Consortium Analytical Instrument Qualification Team
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Chad Briscoe
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PRA
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SESSION I:
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The Electronic Lab Scene
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TBD
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Ron Shoup
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AIT Labs
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Application VelQuest Lab Notebook to Bioanalytical Operations
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Toni Pollock
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Tandem Labs
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Lab Systems Integration Through Automated Reporting
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David Elgar
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Boehringer-Ingelheim
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| Keynote |
FDA Update on Review of Electronic Raw Data and the Current Status of 21 CFS Part 11 & future guidance on auditing E-notebooks and lab software |
Jonathan Helfgott (webcast) |
FDA |
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SESSION II:
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Remote Auditing/Data Monitoring
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Remote Data Monitoring and Auditing
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Scott Davis
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PPD
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Vendor Talk
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TBD
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Larry Elvebak
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Gubbs Inc.
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Session III:
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Data Integration
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Cloud as a Tool
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Mohammad Shaikh
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Bristol-Myers Squibb
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Validation of Cloud Services for Use in a Bioanalytical/Phase 1 CRO
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Merry Danley
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Celerion Pharmaceuticals
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Automated Data Archiving for Preclinial Instrumentation Data
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Viral Vyas
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Bristol-Myers Squibb
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Cocktail Reception
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