Schedule for On-Campus Courses at Fort Washington (RAQA)
FALL 2023 Schedule for the Regulatory Affairs and Quality Assurance Graduate Program
On-Campus Courses Only (listed numerically by Course Number) (updated 8/10)
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.
Note: Due to visa requirements, international students must attend courses on-campus, which includes taking online courses in the Ft Washington computer lab.
DAYTIME ON-CAMPUS COURSE at Fort Washington
5459. Drug Development (Fort Washington) (101) crn: 49409 Registration Form for On-Campus Courses at Fort Washington
2:00 pm - 5:30 pm Thursdays: Sept 14, 21, 28, Oct 5, 12, 19, 26, Nov 2, 9, 16. Meets 10 times plus final exam. Make-ups, if needed, Nov 30 and Dec 7.
In-class, proctored exam: Oct 12
Faculty: P. Sax
Required texts: 1) Drugs: From Discovery to Approval, Ng, 3rd end, 2015 (ISBN-13:978-1118907276 or ISBN-10: 1118907272) 2) The Drug Hunters: The Improbable Quest to Discover New Medicines,
Not open to students who have completed RAQA 459.
WEEKEND ON-CAMPUS COURSE at Fort Washington
5477. Good Manufacturing Practices (101) crn: 51965 Registration Form for On-Campus Courses at Fort Washington
This course is offered both on-campus at Ft Washington or online.
9:00 am - 3:30 pm Saturdays (1/2 hour lunch): Sept 9, 23, Oct 7 (Columbus Day weekend), 21, Nov 4, 18. Meets 6 times plus final exam. Make-ups, if needed, Dec 9 and 16.
Proctored exam: Oct 21
Faculty: R. Phillips
No required text.
Not open to students who have completed RAQA 5477.
WEEKEND ON-CAMPUS COURSE at Fort Washington
5516. Cleaning Validation (101) crn: 42747 Registration Form for On-Campus Courses at Fort Washington
This course is offered both online and on-campus at Fort Washington
9:00 am - 3:30 pm Sundays (1/2 hour lunch): Sept 10, 17, Oct 8 (Columbus Day weekend), 22, Nov 5, 19, Dec 10. Meets 6 times plus final exam. Make-up, if needed, Dec 17. Mandatory field trip: Nov 19.
Proctored exam: Dec 10
Faculty: A. Walsh
Required text: Cleaning Validation: Science, Risk and Statistics-based Approaches, A. Walsh. Order from: www.centerforpharmaceuticalcleaninginnovation.org/textbook-page.html
DAYTIME ON-CAMPUS COURSE at Fort Washington
5592. Food and Drug Law (Fort Washington) (101) crn: 51967 Registration Form for On-Campus Courses at Fort Washington
2:00 pm - 5:30 pm Tuesdays: Sept 12, 19, 26, Oct 3, 10, 17, 24, 31, Nov 7, 14. Meets 10 times plus final exam. Make-ups, if needed, Nov 21 and 28.
In-class, proctored exam: Oct 10
Faculty: C. Hammes
Required texts: 1. Food and Drug Law: Cases and Materials, 4th edition, Hutt, et al, West Academic Publishing. Purchase a used copy of the 4th edition. Do not buy the 5th edition or the 1st - 3rd edition. If you want a new copy, West Academic Publishing gives a 15% discount and free ground shipping to 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 for 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.
Pharmaceutical Science Course – requires strong science background
8002. Pharmaceutical Analysis (Fort Washington) (1) crn: 17006 Registration Form for On-Campus Courses at Fort Washington
This course is offered both online and on-campus at Fort Washington.
Prerequisite: strong science background: 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: Sept 11, 18, 25 (Yom Kippur), Oct 2, 9, 16, 23, 30, Nov 6, 13, 27, Dec 4, 11. Meets 12 times plus final exam. No class Nov 20. Make-ups, if needed, Dec 4 and 11.
Proctored exams: Oct 23 and Dec 11.
Faculty: D. Canney, A. Fermier, S. Mehrman
No required text.
Not open to students who have completed Pharmaceutics 411.
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.