School of Pharmacy & Pharmaceutical Sciences

Department of Industrial & Physical Pharmacy
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Regulatory & Quality Compliance Graduate Certificate Program

An Important Three Course Program Presented by Purdue University, West Lafayette, IN

Instructors: S. Byrn, M. Schmidt, and T. Wilson

With emphasis on Food and Drug Law Drug Discovery & Development Good Regulatory (GXP) Practices
The purpose of this certificate program is to provide graduate level education in the important aspects of Regulatory & Quality Compliance in the pharmaceutical industry. In this way, students will have an opportunity to improve their knowledge: of regulatory and compliance issues and to explore careers in those exciting areas. Additionally, this program provides background information on the drug development process from discovery to the marketplace.
This graduate certificate program consists of three courses, each 3-credit hours that will be presented on weekends (about one weekend per month) at the Purdue University West Lafayette campus. Participants will attend classes 1:00 6:00 PM Fridays, 8:00 AM 6:00 PM Saturdays, and 9:00 AM–12:00 noon Sundays. A homework assignment and exams will be given far each major section of the course. The certificate program consists of the following courses: (1) U.S. Food & Drug Law I, (2) Drug Discovery & Development, and (3) Good Regulatory (GXP) Practices. If taken in successive semesters (fall, spring, and summer), the program can be completed in one calendar year.
The development of this program has been a joint effort between Purdue University, representatives from the pharmaceutical industry (mainly Lilly and Abbott), and the FDA.
Individuals who successfully complete the certificate program will also have the option to apply these 9 credit hours to a Master’s Program in Regulatory & Quality Compliance at Purdue.
Please click here for a complete prospectus of this program
 
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