White Paper Drafting CommitteeTENTATIVE

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White PaperDrafting Committee-TENTATIVE

• Surendra Bansal, Chair
• Rod Allnutt
• Ernie Bush
• Bill Egan
• Marta Hamilton
• Edward Ashley Hankinson
• John Landy
• Tom Layloff
• Steve Lowes
• Moheb Nasr
• Paul St. Jean
• Vinod Shah

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Summing up the Analytical Instrument Validation
Workshop

• Breakout Session Summaries
• Role and Responsibilities of Users, QA,
  Manufacturers and Validation Groups/Consultants
  in Performing Instrument Validation,
• Paul St. Jean, Waters Corp.
• Analytical Instrument Validation in GLP and GMP
  Environments Similarities and Differences,
• Steve Lowes, Ph.D., Advion BioSciences
• Analytical Software Validation (Including LIMS)
  Once or Multiple Times at Multiple Sites?
• Ernest Bush, Ph.D., Hoffmann-La Roche, Inc.

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Summing up the Analytical Instrument Validation
Workshop

• Breakout Session Summaries
• Defining Analytical Instrument Validation and
  Setting a Common Terminology
• Defining Essential Parameters and Developing
  Procedures for Analytical Instruments Validation
• Marta Hamilton, Ph.D., OSI Pharmaceuticals
• 1000 AM Break
• 1020 AM Panel discussion and final summary
• 1130 AM Adjournment

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