Credits		3 credits
Coordinator/Primary Instructor		Dr. David Worthen
Catalog Description		This course will present current Good Manufacturing Practices (cGMP’s) and the current regulatory climate applicable to the manufacture of pharmaceutical products in the United States, including: the drug development process; the regulation of drug products; and the application of current good manufacturing practices to the manufacture of these products, with special emphasis on the changing climate in regulation of these products by the FDA.
Estimated Enrollment		20 (Enrollment is limited to 25 students.  BSPS and pharmaceutical engineering track students have preference for this required course.)

Detailed Course Description

This course will present current Good Manufacturing Practices (cGMP’s) and the current regulatory climate applicable to the manufacture of pharmaceutical products in the United States. The student will enjoy instruction in the drug development process, the regulation of drug products, and the application of current good manufacturing practices to the manufacture of these products.

The course will present, in a lecture format, the principles and documentation requirements of cGMP’s in the manufacture of pharmaceutical products, with special emphasis on the changing climate in regulation of these products by the FDA.  Each student will have an opportunity to identify and research a topic of particular interest, and share his/her findings in the form of both an oral seminar before the class and a final report.

Activities/Class format
This 3-credit course will meet for approximately 3 hours once weekly in a lecture format.  Our lecturers will include a number of distinguished scientists from government, industry and academia.

Grading
Grades for this course will be based upon several factors, including:

An initial research project proposal	10%	(ca. 2-3 pp., identifying a topic, its relevance and importance, a brief background, and rationale/approach for study, availability and sources of information)
A midterm examination	25%
A final research report on the approved research project	25%	(ca. 15 pp. summarizing your findings)
A final examination	30%	(a general exam based upon topics covered in the lectures. Student presentations will not be included in the final exam)
Attendance and participation	10%

 

Learning Objectives

1. To provide an understanding of the overall scheme used in the discovery of new drugs, the development and testing of pharmaceutical products, and their subsequent regulatory approval.
2. To provide an understanding of relevant law, regulations and guidelines, and of the United States Food and Drug Administration (hereinafter, “FDA”).
3. To provide an understanding of good manufacturing principles and related documentation requirements as they apply to the manufacture of pharmaceuticals
4. To discuss the changing climate of regulatory oversight by the FDA and the ramifications on the manufacture of drug products.
5. To provide an opportunity to identify, research, and report on a topic of particular interest for each student.