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ISPE and FDA Discuss Quality Standards at Joint CGMP Conference

June 13, 2012

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ISPE and FDA Discuss Quality Standards at Joint CGMP Conference

ISPE just concluded its two-day CGMP Conference co-sponsored by the FDA (June 4-5, 2012, Baltimore, MD) with resounding support from more than 300 participants to more aggressively advance the Society’s role in facilitating discussions among industry and regulators on issues that strengthen the safety of pharmaceutical products and devices produced around the world.

ISPE assembled an impressive list of FDA speakers, including FDA leaders and drug inspectors, to participate in this conference focused on the importance of driving a culture of quality throughout companies and regulatory agencies. Some enlightening discussions and provocative statements were made by both industry and regulators during the two-day discussions.

The event included talks addressing various aspects of quality from Dr. Janet Woodcock, Deborah Autor, and Ilisa Bernstein from the FDA, as well as MHRA’s Gerald Heddell, and industry experts Andy Skibo (MedImmune) and Mary Oates (Pfizer). Industry leaders answered questions about quality issues, lean manufacturing, and the importance of patient safety during the Industry-Led Hot Topic Discussion Forum.

“I believe Dr. Woodcock (director, Center for Drug Evaluation and Research, FDA) is right in expressing to our industry that we must ‘out’ our inconsistencies,” said Nancy S. Berg, president and CEO of ISPE, the conference host. “Whether the industry is actually in crisis is debatable, but ISPE will certainly be catalytic in leveraging the collective experience and knowledge within companies and regulatory agencies in order to reach technical solutions that go even further to protect the consumer. We need to work more collaboratively to remove barriers and bureaucracy and focus on even better quality solutions, so there will be enough resources to take care of global risks.”

ISPE’s conference addressed how quality management systems and risk management tools are being applied to mitigate risks that could occur as the industry faces pressures to reduce costs and manage complexities in global supply chains. ISPE extended these regulatory discussions at an additional first-time industry event, “Designing, Implementing and Maintaining Pharmaceutical Supply Networks Conference” (June 6-7, Baltimore) with leading experts discussing the importance of knowledge sharing through groups like ISPE as a means of communicating best practices that are designed to ensure safety and security in the pharmaceutical supply chain. Members of global and domestic companies as well as regulatory agencies participated in this new annual ISPE event.

Complete information about the event is available on the CGMP Conference Web site.

For more information on ISPE, visit www.ISPE.org.

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