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ISPE

FDA Compliance

Current Good Manufacturing Practices Conference

Co-sponsored by ISPE and FDA, June 4–5, 2012, in Baltimore

Published: Thursday, March 15, 2012 - 11:38

(ISPE: Tampa, FL) -- The Food and Drug Administration (FDA) has joined with the International Society for Pharmaceutical Engineering (ISPE) to deliver an integrated learning conference focused on industry and regulatory viewpoints concerning current good manufacturing practices (CGMP). The conference, “Redefining the ‘C’ in CGMP—Creating, Implementing, and Sustaining a Culture of Compliance,” will be held in Baltimore, June 4–5, 2012. It is the first joint ISPE-FDA conference focused on CGMP issues.

The conference will feature a new format with a number of audience-participation and interactive sessions. Attendees engage in discussion with regulators on critical industry issues, concerns, and collaboration during the Hot Topic Discussion Forum. A mixed panel of FDA and industry leaders will answer the industry’s most pressing questions during a moderated “Meet the Press” session. Topical plenary and education sessions will be featured throughout the two-day event.

“This first annual co-sponsored conference reflects ISPE’s commitment to engaging its members, companies, and global regulatory agencies in dialogue around critical problem solving and learning,” says ISPE president and CEO Nancy Berg. “As the independent pharmaceutical manufacturing association, ISPE is dedicated to strengthening industry through relevant technical education, training, and networking. This new conference hits the mark, assembling the entire supply chain to discuss industry’s commitment to identifying and adopting quality and manufacturing techniques that continue to deliver a safe, consistent, and available drug supply.”

“FDA is very excited to be working on this joint conference,” says Steven Lynn, the acting director, FDA/CDER/Office of Compliance/Office of Manufacturing and Product Quality. “Our goal is to make this a highly collaborative agency and industry conference, where we can come together to discuss the current and future state of CGMPs in the quest to ensure high-quality, fit-for-use drugs are continually available to the community that we serve.”

More information on the Redefining the “C” in CGMP Conference is available here.

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ISPE

The International Society for Pharmaceutical Engineering (ISPE) is a global nonprofit association of 22,000 pharmaceutical professionals in 90 countries who use knowledge to create high-quality, cost-effective good manufacturing practices (GMP) solutions. ISPE provides its members opportunities to develop technical knowledge, exchange practical experience within their community, enhance their professional skills, and collaborate with global regulatory agencies and industry leaders. Founded in 1980, ISPE offers online learning for a global audience. Its world headquarters are in Tampa, Florida, with offices in Brussels, Belgium, Shanghai, China, and Singapore.