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Drs. Carl Anderson and James Drennen completed training session on Process Analytical Technology and Quality by Design for FDA/international regulators, Sept. 16 – 18, 2009.
Thirty-eight delegates received hands-on training at Duquesne University Mylan School of Pharmacy this week. The participants included U.S. Food and Drug Administration (FDA) compliance officers, international regulators and control systems engineers serving the pharmaceutical industry.
While the Graduate School of Pharmaceutical Sciences and Center for Pharmaceutical Technology are known for their expertise in developing and implementing ways to improve safety, quality and efficacy throughout the industry and have provided their faculty and laboratories for training in the past, this is the first time the federal representatives have invited regulators from other countries—Spain, Australia and Germany—to join the sessions. The domestic and international regulators were joined by representatives of Austin-based Emerson Process Management, which provides equipment used in pharmaceutical manufacturing.
“It’s part of the FDA’s effort to have harmony among regulatory bodies,” explained Dr. James K. Drennen III, associate dean. “Duquesne’s Center for Pharmaceutical Technology has had a sustained effort to educate FDA staff regarding the adoption and implementation of modern technologies and philosophies used during drug development and manufacturing.”
“The training sessions, which ran from Sept. 16-Sept. 18, included lectures on Quality-By- Design, a philosophy for product and process development, and the analytical technologies and control systems needed to implement efficient manufacturing methods that will ultimately guarantee the quality of our nation’s pharmaceuticals,” Drennen said.
Duquesne is the only university in Pennsylvania and one of a handful of institutions nationwide to provide this type of training to FDA staff, who set policy and evaluate the quality of manufacturing facilities and operations.
This training session is one of many collaborations between the Mylan School of Pharmacy and the Graduate School of Pharmaceutical Sciences, government and business partners that seek to address the growing need for new technologies that will ultimately enhance the development and manufacturing of drug products, enabling the pharmaceutical industry to bring safe and effective drugs to market quickly. The Graduate School of Pharmaceutical Sciences is one of eleven leading pharmaceutical engineering universities comprising the National Institute for Pharmaceutical Technology and Education, a consortium that is developing technologies and educational programs on process design, scale-up and validation for drug manufacturers.
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