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University of Wisconsin-Madison

Pharmacy and engineering combine expertise on QbD course

Scientist Holding MoleculeFocusing on quality in manufacturing will minimize cost and reduce waste. A strategic approach to quality improvement is vital when starting a successful drug development project. Quality by Design (QbD) is one aspect of quality that now has FDA endorsement for shortening the drug development timeline. The FDA imperative is outlined in its report “Pharmaceutical Quality for the 21st Century: A Risk-Based Approach.” In the past few years, the agency has implemented the concepts of QbD into its pre-market processes. The focus of this concept is that quality should be built into a product with an understanding of the product and process by which it is developed and manufactured along with a knowledge of the risks involved in manufacturing the product and how best to mitigate those risks. The Division of Pharmacy Professional Development (DPPD) is pleased to partner with the University of Wisconsin-Madison’s College of Engineering to offer “Attaining and Sustaining Quality in the Pharmaceutical Industry,” May 23-27, 2016 in Madison. This is the only continuing education course of its kind and combines experts from the pharmaceutical industry with the expert faculty from the College of Engineering. Students will have the opportunity to work on case studies based on real-world examples. Through instruction and exercises they will recognize the difference between quality and compliance, learn the framework of a quality system, and develop potential counter measures to reduce or eliminate the barriers to process predictability. Join Dr. Louis Yu, President of Great Lakes Pharmaceutical Consultants, LLC (and former Executive Vice President of Global Quality at Perrigo) and Jeff Oelke, MS and Carl Vieth, MS, Program Directors at the College of Engineering as they offer a uniquely practical comprehensive quality course with concepts that you will be to apply to your projects as soon as you return to work. For details, click here.