Risk-Assessment Strategy for Validating Environmental Monitoring Software Determine What to Test and Learn How to Defend Your Rationale

This webcast will begin on Thursday, October 02, 2014 at 01:00 PM EDT.


During this 30-minute webcast, Vaisala’s Senior Regulatory Expert Paul Daniel will explain how to use risk-assessment as a strategy for determining the validation requirements of computerized environmental-monitoring systems. Webinar attendees will learn to use risk assessment to make software validation workload manageable. Paul, who has 17 years of experience with risk assessment, will outline the steps of documenting risk assessment and explain how you can justify validation methods with appropriate rationales. This information will enable attendees to defend their validation decisions during an audit.

Key learning objectives:

  • Learn to use risk assessment tools to identify validation needs
  • Understand your monitoring system within the context of the GAMP process
  • Understand and quantify probability, severity, and detectability
  • Know how to build useful matrices to establish risk class and risk priority

Paul Daniel
Senior Regulatory Compliance Expert

Jennifer Markarian

Manufacturing Editor
Pharmaceutical Technology

This is a FREE streaming audio Webcast and does not require a phone line. If you have any questions regarding this Webcast, please contact Sara Barschdorf, sbarschdorf@advanstar.com.

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