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Home » Store » Drug Products » Quality Metrics Redux - Webinar Recording/Transcript

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Quality Metrics Redux - Webinar Recording/Transcript

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Drug Products

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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  • Important details of the FDA’s latest draft guidance on quality metrics, including what information is to be included in a meeting request and what information FDA would like to see during a site visit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.

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