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Building Processes and Procedures to Ensure Your Site is Audit-Ready

Stuart Cotter
Director, Product Success, Forte
MaryAnn Kempker
Computer System Validation Project Manager, Forte

As any clinical research professional knows, auditing and monitoring are an inevitable part of participating in clinical trials. When facing an FDA or sponsor audit, it’s important to know what types of inquiries you’ll face and how to respond to them. While your site may be compliant, ensuring that your staff can properly respond to questions and access documentation is crucial.

In this webinar, Stuart Cotter, Forte’s Director of Product Success and former Forte eReg Product Manager, and MaryAnn Kempker, Forte’s Computer System Validation Project Manager, provide insight into how your site can proactively plan for audits and monitoring visits.

During this webinar, we discuss:

  • What is typically audited and monitored during a clinical trial
  • Defining roles and responsibilities to prepare for audits and monitoring
  • Building a risk-based approach to 21 CFR Part 11 validation
  • How to test if your site is truly audit-ready

Previously Recorded: February 2019
45 mins

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