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U.S. Department of Health and Human Services

Drugs

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FDA’s Pharmaceutical Quality Initiatives – Implementation of a Modern Risk-Based Approach

February 28 to March 2, 2007
Bethesda North Marriott Hotel and Conference Center
Bethesda, Maryland

Objectives:

  • To explore FDA’s quality initiatives and share progress made since the issuance of the Agency’s 2004 report, “Pharmaceutical cGMPs for the 21st Century – A Risk-Based Approach”.
  • To provide updates from the FDA’s Council on Pharmaceutical Quality, with a focus on implementation challenges and remaining issues
  • To seek input and recommendations from stakeholders

Abstract: This workshop is a follow up to the PQRI/FDA Workshop on "A Drug Quality System for the 21st Century" held in April 2003. It is being planned under the auspices of the Council on Pharmaceutical Quality at FDA and is co-sponsored with the American Association of Pharmaceutical Scientists and the International Society of Pharmaceutical Engineers. The 2-1/2 day program is intended to present progress on FDA’s pharmaceutical quality initiatives. Furthermore, the workshop will allow regulated industry, other stakeholders, and the public to comment on progress made and to provide input to facilitate implementation of a common vision for pharmaceutical manufacturing in the 21st century. Among topics to be addressed: pharmaceutical development, chemistry, manufacturing and controls (CMC), manufacturing and quality operations, good manufacturing practices (GMP), quality systems and quality assurance.