WHAT: AAPS and ISPE are pleased to present the FDA's Pharmaceutical Quality Initiatives: Implementation of a Modern Risk-Based Approach, an interactive workshop that will provide updates on the progress of the FDA's pharmaceutical quality initiatives since the 2004 report "Pharmaceutical GMPs for the 21st Century," and will serve as an open forum for industry, other stakeholders, and the public to take part in the dialogue about the future of pharmaceutical manufacturing. Topics to be addressed in the 2-1/2 day program include drug development; chemistry, manufacturing, and controls (CMC); manufacturing and quality operations; good manufacturing practices (GMP); quality systems; and quality assurance.
WHO: The American Association of Pharmaceutical Scientists (AAPS) is a professional, scientific society of more than 13,000 members employed in academia, industry, government, and other research institutes worldwide. Founded in 1986, AAPS provides a dynamic international forum for the exchange of knowledge among scientists to enhance their contributions to health. AAPS offers timely scientific programs, on-going education, information resources, opportunities for networking, and professional development. This workshop is co-sponsored by the U.S. Food and Drug Administration (FDA) and the International Society for Pharmaceutical Engineering (ISPE).
WHY: This workshop is a follow-up to the PQRI/FDA Workshop on "A Drug Quality System for the 21st Century" held in April 2003 and 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.
WHEN: February 28 March 2, 2007
WHERE: Bethesda North Marriott
5701 Marinelli Road
North Bethesda, MD 20852