ISPE announced that the Food and Drug Administration (FDA) will co-sponsor the upcoming “Redefining the ‘C’ in ‘CGMP’” Conference in Baltimore on June 4–5, 2012. The conference 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. A Hot Topic Discussion Forum between attendees and regulators will feature discussion on critical industry issues, concerns and collaboration. A mixed panel of FDA and industry leaders will also 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 dialog around critical problem-solving and learning,” said ISPE’s 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,” said Steven Lynn, acting director, FDA/CDER/Office of Compliance/Office of Manufacturing and Product Quality (OMPQ). “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 at www.ISPE.org/2012CGMPCompliance.