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University Provides Hands-On Demonstration to FDA

Faculty and graduate students of the Mylan School of Pharmacy provided three days of technical demonstrations to Food and Drug Administration (FDA) employees, geared toward raising the quality and efficiency of pharmaceutical manufacturing.

Thirty-six FDA reviewers, who evaluate new drug applications from pharmaceutical manufacturers, and inspectors who evaluate the quality of manufacturing facilities and operations, participated in the Duquesne program Sept. 18-20, receiving practical experience in modern process development and pharmaceutical manufacturing. Duquesne, which has previously provided national and international technical leadership to the FDA and the pharmaceutical industry, is one of only a few universities to offer such advanced experiences to FDA personnel, said Dr. James K. Drennen III, Mylan School of Pharmacy associate dean.

“The program provided practical and laboratory-based, hands-on experience that is difficult to emulate elsewhere,” Drennen said.

The training session utilized a state-of-the-art control system, which was recently donated to the Mylan School of Pharmacy by Emerson Process Management and installed by Emerson’s local representative, the Pittsburgh-based Equipment and Controls Inc.

Mylan School of Pharmacy Dean J. Douglas Bricker said, “The new control system will enhance the research of the Duquesne University Center for Pharmaceutical Technology in the areas of process control and manufacturing efficiency in both primary and secondary pharmaceutical manufacturing operations.”

“For both Equipment and Controls, and Emerson, this step was important in forging a strategic alliance with Duquesne University, allowing all parties to share strategies and explore new areas,” said Jeff Scott, president of Equipment and Controls.

Other business partners collaborating with Duquesne University were Optimal Industrial Automation, Control Development Inc. and Eigenvector.

“Duquesne researchers continue to work with the pharmaceutical industry on funded research that seeks to improve process and product development,” Drennen said. “Integrating this equipment into the systems already in place has enhanced our ability to work with the pharmaceutical industry on process development issues. Our continuing relationship with the FDA and the industry’s growing need for advanced process control systems should provide additional opportunities for Duquesne to play a role in bringing

Duquesne University

Founded in 1878, Duquesne is consistently ranked among the nation's top Catholic universities for its award-winning faculty and tradition of academic excellence. Duquesne, a campus of nearly 9,500 graduate and undergraduate students, has been nationally recognized for its academic programs, community service and commitment to sustainability. Follow Duquesne University on Facebook, Twitter and Instagram.