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  • Which CSV Model Should you Use: V-model, GAMP 5 or ASTM

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Thursday - Apr 04, 2013 10:00 AM
  • End Time:
  • Thursday - Apr 04, 2013 11:00 AM
  • Location:
  • Online
  • This training on computer system validation models will explain the distinctions and similarities between three CSV models - V-model, GAMP 5 and ASTM E2500 - and show how you can apply the most appropriate model for your application and significantly reduce your regulatory risk.

    Why Should You Attend:

    Computer Systems Validation (CSV) has significantly evolved over the past few years. It is no longer an exercise which involves “10 easy steps to CSV”. CSV’s complexity has evolved due to the regulations of the past few years. Consequently, approaches using the classical V model to devise a ten step approach to validation no longer holds true. This is corroborated by the introduction of validation models such as GAMP 5, ASTM 2500 etc. It is critical to obtain an understanding of the distinctions between these models and choosing one that is appropriate for your application. Failure to do so will increase your exposure to audit failure.

    This Intermediate to Advanced level webinar from a CSV implementation expert will expand your CSV knowledge and familiarize you with the following:

    - An enhanced collapsed CSV architecture to save you time and money and reduce regulatory risk.
    - Use of The Capability Maturity model to decrease CSV costs
    - How not to fall a victim of “Tag along audits” by the FDA
    - Why is Quality Risk Management critical for a successful audit of your CSV efforts
    - How is QRM audited

    At the conclusion of this webinar, you will be able to determine whether your company’s CSV strategy is vulnerable to the most common violations and what you need to do plug these vulnerabilities.
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