Quality Metrics - Why it Matters?
*Lawrence Yu, FDA/CDER/OPQ Keywords: The FDA has within the past month issued a draft guidance on Quality Metrics. To provide a deeper understanding of the concepts embodied in the draft guidance, I will discuss the importance of QbD concepts to the evolution of Quality Metrics, the FDA rationale for its development and expand on the OPQs vision intended to enhance the role of a quality culture within industry. Outline 1. Product quality in relation to QbD a. QbD principles and objectives b. QbD during development and commercialization 2. FDA rationale for the development of quality metrics a. Overview of draft quality metrics guidance b. Relationships between the cGMP and quality metrics 3. Quality evolution
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Key Dates
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June 3, 2014 - September 7, 2015
Online Registration -
June 3, 2015 - August 15, 2015
Housing -
July 31 - August 17, 2015
Invited Abstract Editing -
August 10, 2015
Short Course materials due from Instructors -
August 26, 2015
Advanced Registration Deadline -
September 7, 2015
Cancellation Deadline -
September 16 - 18, 2015
Marriott Wardman Park, Washington, DC