Track 2: Laboratory

There are common threads in many compliance problems experienced in the laboratory. Do you know what they are?

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Validation of a computerized system is just as critical in a laboratory as it is in Manufacturing. Gain a better understanding of what the Regulatory Agencies are looking for in relation to Quality Systems. Learn through case studies and get immediate feedback from subject-matter experts and FDA representatives on how to take a risk-based approach to the validation of laboratory computerized systems with GAMP®5.

How You Will Benefit

At the conclusion of this session, participants will be able to:

  • Apply new risk-based concepts related to laboratory systems validation as presented in the new GAMP Good Practice Guide



    Who Should Attend

    • GAMP COPs
    • Laboratory Managers
    • Scientists
    • Quality Assurance Professionals

    Pinnacle Programme
    2011 Global Sponsor