Quality Metrics Redux - Webinar Recording/Transcript
Quality Metrics Redux: Taking Advantage of FDA’s Renewed Focus
The FDA is trying to learn all it can about quality metrics.
The agency began a year-long voluntary site visit program in August to learn what types of metrics drugmakers collect — and which are the best indicators of quality success or failure. It intends to use quality metrics to support its risk-based inspection planning with mandatory participation.
A scary prospect? Maybe.
A valuable opportunity? Almost definitely.
Mark your calendar for a strategy session with two knowledgeable industry activists, Steven Mendivil of Amgen and Denyse Baker of AstraZeneca. Over the course of fast-paced 90-minutes, they’ll explain the latest developments and what they mean for you. You’ll discover:
- How the pilot program is progressing and what the FDA has learned so far
- How to take advantage of opportunities to provide input to the FDA before it drafts regulations to implement the program, including contact with appropriate agency personnel
- Important details of the FDA’s latest draft guidance on quality metrics, including what information is to be included in a meeting request and what information FDA would like to see during a site visit
- Major industry concerns, such as metrics selection and definitions, and how the agency is addressing them
- And much more
Quality metrics is no longer a distant dream. It’s coming — and you need to prepare your quality system to meet it.