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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.
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Date created: July 28, 2006 |
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