Duquesne Pharmacy School Provides FDA with State-of-the-Art Training
The fingerprints of Duquesne University's Mylan School of Pharmacy are all over a massive training effort for new federal Food and Drug Administration reviewers.
As part of the 13-member nonprofit National Institute for Pharmaceutical Technology and Education (NIPTE) consortium, Duquesne faculty members Dr. Carl Anderson of Cranberry Township, director of the Duquesne Center for Pharmaceutical Technology and associate professor of pharmaceutics; Dr. Peter Wildfong of Franklin Park, associate professor; and Dr. Ira Buckner of Mount Lebanon, assistant professor, have received about $66,000 in grants to provide about one-third of the entire 30-hour FDA training course.
The two-year project, Reviewer Education in State-of-the-Art Pharmaceutical Manufacturing Technology, provides live audio synchronized with Power Point slides that is required training for all new FDA reviewers who provide drug manufacturing process approvals, Anderson said.
The Duquesne professors have worked on basic training modules that will kick start the FDA's invigorated training efforts in drug substance, drug products, analytics, statistics and quality risk management systems. Topics include structure and process, risk assessment, identification analysis, identification and control, risk communication and risk management tools. These modules give FDA reviewers better understanding of the physical characterizations of drug substances, formulations and attributes of tablets and capsules.
Additionally, Anderson has received funding to provide advanced quality risk management training in August on-site in the FDA's Washington, D.C. offices.
"These live sessions of limited-size classes in reviewing development decisions, allow reviewers to see trends in drug manufacturing," Anderson said.
He anticipates additional funding on how to globalize drug manufacturing review, "sharing insights with thousands instead of tens of reviewers," Anderson said.
Duquesne has served an active role in NIPTE, with Dr. James Drennen, Noble J. Dick Chair in Academic Leadership and associate dean for graduate programs and research, completing a project focused on the development of building quality control elements into the manufacture of drugs. Drennen is Duquesne's lead faculty representative for NIPTE; Dr. Alan Seadler, associate academic vice president for research, serves as the board's treasurer.