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Risk-based Validation Considerations when Implementing Clinical Research Systems

Presented by Susan Nonemaker-Cox

Clinical research systems support various business functions and processes within a sponsor organization, and are classified differently from a regulatory compliance perspective based on their intended use. If data is submitted to the Food and Drug Administration (FDA), the system used to capture this data must be validated.

By leveraging a risk-based validation methodology, you can tailor your validation strategy to the specific type of system and implementation nuances; assigning practical validation roles and responsibilities. In this webinar, senior associate, Susan Nonemaker-Cox, will provide an overview of a typical validation checklist and risk-based validation considerations both the sponsor and vendor should follow during clinical research system implementation.

You’ll learn how to:

  • Apply a risk-based methodology when creating a project-level validation strategy and related validation deliverables
  • Identify key considerations for establishing an SOP/Guidelines strategy
  • Develop training requirements and considerations for computer systems validation (CSV) and/or regulatory training (21 CFR Part 11)

Previously recorded: July 21, 2016
60 minutes

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