Spring 2024 Schedule for the Regulatory Affairs and Quality Assurance Graduate Program
On-Campus Courses Only (listed numerically by Course Number) (updated 12/8)
Please check class dates carefully. Students who cannot make scheduled exams will be charged a $25.00 fee for an initial makeup exam. The fee increases to $50.00 for the second missed exam and then $100.00 for the third exam. For more on this policy, click here. To comply with U.S. visa requirements, full-time international students must register for and attend on-campus courses. This includes taking online courses in the Ft Washington computer lab.
DAYTIME ON-CAMPUS COURSE at Fort Washington
5592. Food and Drug Law (101) crn: 51042 Registration Form for On-Campus Courses at Fort Washington
2:00 pm - 5:30 pm Mondays: Jan 29, Feb 5, 12, 19 (nts’ Day), 26, Mar 4, 11, 18, 25, Apr 1. Meets 10 times plus final exam. Make-ups, if needed, Apr 8 and 15.
In-class, proctored exam: Feb 26
Faculty: C. Hammes
Required texts: 1. Food and Drug Law: Cases and Materials, FOURTH edition (you may purchase a used book), Hutt, et al, West Academic Publishing. Purchase the 4th edition. Students who prefer a new copy may buy it from West Academic Publishing, at a 15% discount and free ground shipping for students ordering these texts. You must create an account, use promo code HESTUDENT, and place your order directly through www.westacademic.com. 2.FDCA Statutory Supplement: Access free at: https://uscode.house.gov/view.xhtml?path=/prelim@title21&edition=prelim (scroll to chapter 9).
Not open to students who have completed RAQA 592.
WEEKEND COURSE at Fort Washington
5591. Global Regulatory Affairs (101) crn: 53060 Registration Form for On-Campus Courses at Fort Washington
This course is offered both on-campus at Ft Washington and online.
Prerequisite: Drug Development (5459) or Food and Drug Law (5592).
9:00 am – 3:30 pm Saturdays (1/2 hour lunch): Jan 13, 27, Feb 10, 24, Mar 9, 23. Meets 6 times plus final exam. Make-ups, if needed, Apr 13 and 27.
In-class proctored exam: Feb 24 (Ft Washington)
Faculty: R. Phillips
No required text.
Not open to students who have completed RAQA 591.
LATE AFTERNOON COURSE at Fort Washington (description below).
5650. Pharmaceutical Regulatory Leadership (101) crn: 53077 Registration Form for On-Campus Courses at Fort Washington
Suggested prerequisites: Drug Development (5459) or Food and Drug Law (5592).
3:00 pm – 6:30 pm Wednesdays: Jan 17, 24, 31, Feb 7, 14, 21, 28, Mar 6, 13, 20. Meets 10 times plus final exam. Make-ups, if needed, Mar 27 and Apr 3.
In-class, proctored exam: Feb 14.
Faculty: P. Sax
No required text.
Suggested texts: The Practice of Management, P Drucker; The Definitive Drucker, E. H. Edersheim, Who Moved My Cheese, S Johnson.
Description: Leading in the pharmaceutical industry requires more than regulatory knowledge: it requires key skills to get the job done with various constituents, including coworkers, employees, and management. This course provides insights, rules, tools and requirements needed to lead in the highly regulated pharmaceutical industry. Students will study organizational principles and practices within the framework of the Code of Federal Regulations (specifically 21 CFR 210, 211, 312, 600 and 820). While these regulations provide what is required, they do not describe how to accomplish it. That task is the job of leadership. Using recommended texts, case studies, class lectures, discussions, and individual research, students will learn how to lead and manage in a regulated industry. Participants will gain the insights to support career goals with new understandings of the work and responsibilities that go along with the titles.
EVENING COURSE at Fort Washington
8006. Physical Pharmacy (101) crn: 53089 Registration Form for On-Campus Courses at Fort Washington
Special note: this course is only offered every other spring semester. The next time it will be offered is Spring 2026, so if you need this for your major, please plan accordingly
This course is offered both at Ft Washington and online.
Prerequisite: A strong science and math background, which includes a science degree (pharmacy, chemistry, biochemistry, biological or chemical engineering), and at least one course in physical chemistry. RAQA students must include resume with registration form.
6:00 pm - 9:00 pm Tuesdays: Jan 16, 23, 30, Feb 6, 13, 20, 27, Mar 5, 12, 19, 26, Apr 2, 9. Meets 12 times plus final exam. Make-ups, if needed, Apr 16 and 23.
Proctored exam: Apr 9
Faculty: D. Lebo
Required text: Martin’s Physical Pharmacy and Pharmaceutical Sciences, J. Sinko, Lippincott Williams & Wilkins, 6th ed., (ISBN: 9780781850271).
Not open to students who have taken Pharmaceutics 485.
EVENING COURSE at Fort Washington
8007. Applied Pharmaceutics (101) crn: 51380 Registration Form for On-Campus Courses at Fort Washington
This course is offered both at Fort Washington and online.
Prerequisite: Strong science background required, including a minimum of 2 years of general chemistry, including one organic and one analytical chemistry course. RAQA students must submit their resume for written permission to register.
5:30 pm – 8:30 pm Mondays: Jan 22, 29, Feb 5, 12, 19 (Presidents' Day), 26, Mar 4, 11, 18, 25, Apr 1, 8, 15. Meets 12 times plus final exam. Make-ups, if needed, Apr 22 and 29.
Proctored exam: Apr 15
Faculty: R. Fassihi
No required text.
Not open to students who have completed Pharmaceutics 410.
Registration Form for On-Campus Courses at Fort Washington
Is this your first RAQA registration with Temple? If so, you must include a RESIDENCY FORM
Is this your fourth class with the RA and QA program? If so, you must include a Non-Matriculated Graduate Student Waiver.
Do you want to apply for the MS in RA and QA? Click here to get started.
PRINT AND FAX YOUR FORMS TO: 267.468.8565
You may also email your forms to: QARAREG@temple.edu
or, mail your forms to:
Temple University
Regulatory Affairs and Quality Assurance (RA and QA) Graduate Program
425 Commerce Drive, Suite 175
Ft. Washington, PA 19034
Phone: 267.468.8560
To receive a complete refund for a course, you must notify the RA and QA Office in writing that you are dropping BEFORE the second class takes place (weekend courses) or BEFORE the third class takes place (weeknight courses). Please use the Course Withdrawal Form.