Everything you Want to Know about the FDA's new Quality Metrics Guidance - Webinar

  • ID: 3734841
  • Webinar
  • 60 Minutes
  • Pathwise
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The FDA released a Request for Quality Metrics Guidance document in July of this year. While the guidance on Quality Metrics not binding, it is a tool to understand the thinking and direction of CBER and CDER on Quality Metrics, and their expectations for continuous improvement.

This webinar will provide a high level overview of the Quality Metrics Guidance Document to help attendees:

- Provide overview of FDA approach to Quality Metrics
- Understand who is impacted and what data is required
- Outline types of metrics addressed in the guidance
- Explain how the FDA intends to use quality metrics
- Discuss optional metrics related to Quality Culture and Process capability
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Kenrick Harrigan
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