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ISPE and FDA Discussed Strengthening Safety at Joint CGMP Conference

Conference addressed how tools are being applied to mitigating risks and manage global supply chains

Published: Tuesday, June 12, 2012 - 11:35

(ISPE: Tampa, FL) -- The International Society for Pharmaceutical Engineering (ISPE) just concluded its two-day current good manufacturing practices (CGMP) conference, which was co-sponsored by the U.S. Food and Drug Administration (FDA). Held June 4–5, 2012, in Baltimore, the conference met with resounding support from more than 300 participants, who discussed how to more aggressively advance ISPE’s role in facilitating discussions among industry and regulators on issues that strengthen the safety of pharmaceutical products and devices produced around the world.

This conference focused on the importance of driving a culture of quality throughout companies and regulatory agencies. It 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.

Industry leaders answered questions about quality issues, lean manufacturing, and the importance of patient safety during the industry-led Hot Topic Discussion Forum. The event included talks addressing various aspects of quality from:
• Janet Woodcock, M.D., the director of the Center for Drug Evaluation and Research at the FDA
• Deborah Autor, the FDA’s deputy commissioner for global regulatory operations and policy
• Ilisa Bernstein, the director of the Office of Compliance at the FDA’s Center for Drug Evaluation and Research
• Gerald Heddell, the director of inspection, enforcement, and standards from the Medicine and Healthcare Products Regulatory Agency (MHRA)
• Andy Skibo of MedImmune, developer, manufacturer, and marketer of formulations used in immunization programs
• Mary Oates of Pfizer, the world’s largest research-based pharmaceutical company

“I believe Dr. Woodcock is right in expressing to our industry that we must ‘out’ our inconsistencies,” says 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 extended these regulatory discussions on mitigating risks while reducing costs and managing global supply chains at an additional first-time industry event, “Designing, Implementing, and Maintaining Pharmaceutical Supply Networks Conference,” held June 6–7, 2012, also in Baltimore, where leading experts discussed 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 website.


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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.