The FDA released a Request for Quality Metrics Guidance document in July of 2015. 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.
Learning Objectives:
- 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
