Spring 2024 Schedule for the RAQA Graduate Program (Updated: December 8, 2023)
All courses are listed in numerical order in East Coast Time (remember to adjust accordingly for your time zone)
Registration Form for Online Courses
Expectations of Online Students
All RAQA online courses use Zoom, which is provided for free to all registered Temple students.
Required hardware
RAQA online courses are interactive. Your computer or laptop must have a webcam and microphone. Many laptops have built-in webcams and speakers. If your laptop does not, you will be required to purchase them.
If you are a new student or are using Zoom for the first time, watch the online course tutorial. A password is given at the end which you must include on the registration form.
After watching the tutorial, schedule an online meeting with David Brickett ([click-for-email]) or Mike Doukas ([click-for-email]) to review how Zoom works, so you'll be ready for your first online class meeting.
RPNow is an online proctoring service, which enables you to take exams at almost any location. RPNow charges $15.00 per exam, which you must pay with a credit card when the exam starts. (You must also pay that fee if you use RPNow in a Temple computer lab.) If a course uses RPNow, all students in the class must use that service.
RPNow exams require a laptop or computer. Chrome notebooks, iPads, cell phones and other devices will not work. You must also have administrative access to your laptop or computer, which means you can install software. (Many office computers have built-in firewalls that will not allow software downloads.) Please check this before registering.
Use Chrome or Firefox for your Browser.
Check class dates carefully. You are expected to take proctored exams on the scheduled date. If you do not, you will be charged $25.00 for an initial makeup exam; $50 for the second missed exam, and $100 per exam thereafter. For more on this policy, click here.
5000. KENX Conferences 1.5 credit hours each section Expectations of Online Students Registration Form for Online Courses
Attend KENX Conferences in-person or On-Demand, or both! On-Demand recordings provide flexibility with completing 18 hours of conference talks at your own pace over 6-weeks. You could complete 1.5 credits during the winter break! Topics this semester include:
Computer Systems Validation & Software Assurance, Dec 5-7, San Diego, CA or virtual Expectations of Online Students Registration Form for Online Courses
https://kenx.org/conferences/2023-computer-systems-validation-software-assurance-university/
5000 (007) crn: 48648 - in person (San Diego)
5000 (990) crn: 53078 - virtual
Validation U, March 5 – 7, San Diego, CA, or virtual Expectations of Online Students Registration Form for Online Courses
5000 (008) crn: 48653 - in person (San Diego)
5000 (991) crn: 48655 - virtual
WEEKEND COURSE
5451. Statistical Quality Control (SQC) (990) crn: 53061 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
8:30 am – 2:00 pm Sundays: Jan 14, 28, Feb 11, 25, Mar 10, 24, Apr 14. Meets 7 times plus final exam. Make-up, if needed, Apr 28.
Proctored exam: Feb 25 (RPNow)
Faculty: R. Snee
Required text: Statistical Quality Control, 7th or latest edition, D.C. Montgomery.
Not open to students who have completed RAQA 451.
WEEKEND COURSE
5459. Drug Development (990) crn: 42713 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
10:00 am – 1:00 pm Saturdays: Jan 20, 27, Feb 3, 10, 17, 24, Mar 2, 9, 16, 23, Apr 6, 13. Meets 12 times plus final exam. No class March 30. Make-ups, if needed, Apr 20 and 27.
Proctored exam: Mar 2 (RPNow)
Faculty: D. Walsh
Required texts: 1) Drugs: From Discovery to Approval, Ng, 3rd edition, 2015 (ISBN-13:978-1118907276 or ISBN-10: 1118907272), and 2) The Great Influenza, John M. Barry, Penguin 2004-5, (ISBN 0-14-303649-1)
Not open to students who have completed RAQA 459.
5459. Drug Development (991) crn: 28687 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
6:00 pm - 9:00 pm Wednesdays: Jan 17, 24, 31, Feb 7, 14, 21, 28, Mar 6, 13, 20, 27, Apr 3. Meets 12 times plus final exam. Make-ups, if needed, Apr 10 and 17.
Proctored exam: Feb 28 (RPNow)
Faculty: J. Hayes
Required text: Drugs, From Discovery to Approval, third edition, Rick, Ng. ISBN: 978-1-118-90726-6.
In addition, students will be required to choose one of the following texts and write a book review:
1) The Poison Squad: One Chemist's Single-Minded Crusade for Food Safety at the Turn of the Twentieth Century, Paperback – Illustrated, Sep 2019, Deborah Blum OR
2) The Jungle, Paperback, 2019, Upton Sinclair
3) The Great Influenza: The Story of the Deadliest Pandemic in History, Paperback – Oct 2005, John M. Barry
4) The Antidote: Inside the World of New Pharma, Barry Werth.
Not open to students who have completed RAQA 459.
5459. Drug Development (992) crn: 51026 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
6:00 pm – 9:00 pm Thursdays: Jan 18, 25, Feb 1, 8, 15, 22, 29, Mar 7, 14, 21, 28, Apr 4. Meets 12 times plus final exam. Make-ups, if needed, Apr 11 and 18.
Proctored exam: Feb 29 (RPNow)
Faculty: To be announced.
Required text: Drugs, From Discovery to Approval, third edition, Rick, Ng. ISBN: 978-1-118-90726-6.
Not open to students who have completed RAQA 459.
5468. Validation of FUE (Facilities, Utilities and Equipment) (990) crn: 42717 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
Prerequisite: Good Manufacturing Practices (5477) or appropriate industry experience in GMPs.
7:15 pm – 10:15 pm Wednesdays: Jan 17, 24, 31, Feb 7, 14, 21, 28, Mar 6, 13, 20, 27, Apr 3. Meets 12 times plus final exam. Make-ups, if needed, Apr 10 and 17.
Proctored exam: Feb 28 (RPNow)
Faculty: E. Muegge
No required text.
5471. Biotechnology: Bioprocess Basics (990) crn: 28688 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course will use RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
Prerequisites: Science background, such as a BS (or higher) in Pharmacy, Chemistry, Biology or Engineering. RAQA students must submit their resume for written permission to register.
6:00 pm – 9:00 pm Wednesdays: Jan 17, 24, 31, Feb 7, 14, 21, 28, Mar 6, 13, 20, 27, Apr 3. Meets 12 times plus final exam. Make-ups, if needed, Apr 10 and 17.
Proctored exam: Feb 28 (RPNow)
Faculty: J. Quinn
No required text.
Not open to students who have completed RAQA 481, Pharmaceutics 475 or Pharmaceutics 5471.
5473. Generic Drug Regulation (ANDAs) (990) crn: 53062 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
Prerequisite: Drug Development (5459).
6:00 pm – 9:00 pm Thursdays: Jan 18, 25, Feb 1, 8, 15, 22, 29, Mar 7, 14, 21, 28, Apr 4. Meets 12 times plus final exam. Make-ups, if needed, Apr 11 and 18.
Proctored exam: Feb 29 (RPNow)
Faculty: C. Ciliberto
No required text.
Not open to students who have completed RAQA 483.
5474. Process Validation (990) crn: 51030 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course will use RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
Prerequisites: Strong science background, such as a BS (or higher) in Pharmacy, Chemistry, Biology or Engineering and a basic understanding of pharmaceutical manufacturing processes. RAQA students must submit their resume for written permission to register.
6:00 pm – 9:00 pm Thursdays: Jan 18, 25, Feb 1, 8, 15, 22, 29, Mar 7, 14, 21, 28, Apr 4. Meets 12 times plus final exam. Make-ups, if needed, Apr 11 and 18.
Proctored exam: Feb 29 (RPNow)
Faculty: K. Barnthouse
Required texts: 1) Process Validation in Manufacturing of Biopharmaceutics, 3rd edition, Anurag S. Rathore and Gail Softer, editors, CRC Press 2012, AND 2) How to Validate a Pharmaceutical Process, 1st edition, Steven Ostrove, Eisevier, 2016.
Not open to students who completed RAQA 484 or Pharmaceutics 8484.
5477. Good Manufacturing Practices (990) crn: 3439 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
6:15 pm - 9:30 pm Thursdays: Jan 18, 25, Feb 1, 8, 15, 22, Mar 14, 21, Apr 4, 11, 18. Meets 10 times plus final exam. No class Feb 29, Mar 7, or Mar 28. Make-up, if needed, Apr 25.
Proctored exam: Apr 18 (RPNow)
Faculty: M. Noonan
No required text.
Not open to students who have completed RAQA 487.
5493. Sterilization Processes (990) crn: 53063 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
Prerequisites: Strong science background. Include resume with registration form.
6:00 pm - 9:00 pm Thursdays: Jan 18, 25, Feb 1, 8, 15, 22, 29, Mar 7, 14, 21 (recording), Apr 4, 11, 18. Meets 12 times plus final exam. No class Mar 28. Make-ups, if needed, Apr 25 and May 2.
Proctored exam: Apr 18 (RPNow)
Faculty: D. Casaburi
Required text: Validation of Pharmaceutical Processes, 3rd edition, ISBN0:0-8493-7055-8.
Not open to students who have completed RAQA 493.
5494. Quality Audit (990) crn: 31574 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
Prerequisite: a good practices course: GLPs (5476), GMPs (5477), Advanced GMPs (5479), or GCPs (5536).
7:00 pm - 10:00 pm Wednesdays: Jan 17, 24, 31, Feb 7, 14, 21, 28, Mar 6, 13, 20, 27, Apr 3, 10. Meets 12 times plus final exam. Make-ups, if needed, Apr 17 and 24.
Proctored exams: Feb 28 and Apr 10 (RPNow)
Faculty: J. Werrmann
Required text: The ASQ Certified Quality Auditor, 5th edition, Lance B Coleman Sr. Available from ASQ Quality Audit Press: www.asq.org/quality-press, ISBN 978-1-951058-09-8, copyright 2020. (Previous editions released as The ASQ Audit Handbook). Note: purchase a hard copy of the 5th edition. Do not buy earlier editions or ebooks.Not open to students who have completed RAQA 494.
DAYTIME ONLINE COURSE with recordings
5494. Quality Audit (991) crn: 39720 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
Prerequisite: a good practices course: GLPs (5476), GMPs (5477), Advanced GMPs (5479), or GCPs (5536).
Noon - 1:00 pm Tuesdays and Thursdays (Eastern time), plus one hour recording each week, which students must watch before the next scheduled class:
Jan 23, 25 - watch recording before Jan 30
Jan 30, Feb 1 - watch recording before Feb 6
Feb 6, 8 - watch recording before Feb 13
Feb 13, 15 - watch recording before Feb 20
Feb 20, 22 - watch recording before Feb 27
Feb 27, 29 - watch recording before Mar 5
Mar 5, 7 - watch recording before Mar 12
Mar 12, 14 - watch recording before Mar 19
Mar 19, 21 - watch recording before Mar 26
Mar 26, 28 - watch recording before Apr 2
Apr 2, 4 - watch recording before Apr 9
Apr 9, 11 (last live class)
Make-ups, if needed, Apr 16 and 18.
Proctored exam: Mar 7 (RPNow)
Faculty: T. Preziosi
Required text: The ASQ Certified Quality Auditor, 5th edition, Lance B Coleman Sr. Available from ASQ Quality Audit Press: www.asq.org/quality-press, ISBN 978-1-951058-09-8, copyright 2020. (Previous editions released as The ASQ Audit Handbook). Note: purchase a hard copy of the 5th edition. Do not buy earlier editions or ebooks.
Not open to students who have completed RAQA 494.
5494. Quality Audit (992) crn: 53064 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
Prerequisite: a good practices course: GLPs (5476), GMPs (5477), Advanced GMPs (5479), or GCPs (5536).
6:00 pm – 9:00 pm Thursdays: Jan 18, 25, Feb 1, 8, 15, 22, 29, Mar 7, 14, 21, 28, Apr 4. Meets 12 times plus final exam. Make-ups, if needed, Apr 11 and 18.
Proctored exam: Mar 7 (RPNow)
Faculty: K. Huynh-Ba
Required text: The ASQ Certified Quality Auditor, 5th edition, Lance B Coleman Sr. Available from ASQ Quality Audit Press: www.asq.org/quality-press, ISBN 978-1-951058-09-8, copyright 2020. (Previous editions released as The ASQ Audit Handbook). Note: purchase a hard copy of the 5th edition. Do not buy earlier editions or ebooks.
Not open to students who have completed RAQA 494.
5495. IND/NDA Submissions (990) crn: 20675 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
Prerequisite: Drug Development (5459) or Food and Drug Law (5592).
6:00 pm – 9:00 pm Tuesdays: Jan 16, 23, 30, Feb 6, 20, 27, Mar 5, 12, 19, 26, Apr 2, 9. Meets 12 times plus final exam. No class Feb 13. Make-ups, if needed, Apr 16 and 23.
Proctored exam: Mar 5 (RPNow)
Faculty: A. Smith
No required text.
Not open to students who completed RAQA 495.
WEEKEND COURSE
5495. IND/NDA Submissions (991) crn: 31567 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
Prerequisite: Drug Development (5459) or Food and Drug Law (5592).
8:30 am - 2:00 pm Saturdays (1/2 hour lunch): Jan 20, Feb 3, 17, Mar 2, 16, Apr 6, 20. Meets 7 times plus final exam. Make-up, if needed, Apr 27.
Proctored exam: Mar 2 (RPNow)
Faculty: P. Smith
Required text: New Drug Development: A Regulatory Overview, Mathieu, 8th revised edition.
Not open to students who completed RAQA 495.
5502. Regulation of Medical Devices: Submissions (990) crn: 53065 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
6:00 pm - 9:00 pm Thursdays: Jan 18, 25, Feb 1, 8, 15, 22, 29, Mar 7, 14, 21, 28, Apr 4. Meets 12 times plus final exam. Make-ups, if needed, Apr 11 and 18.
Proctored exam: Feb 29 (RPNow)
Faculty: M. Arentz
No required text.
Not open to students who have completed RAQA 500.
5503. Design Controls for Medical Devices and Combination Products (990) crn: 48475 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
6:00 pm – 9:00 pm Mondays: Jan 22, 29, Feb 5, 12, 19 (Presidents’ Day), 26, Mar 4, 11, 18, 25, Apr 1, 8. Meets 12 times plus final exam. Make-ups, if needed, Apr 15 and 22.
Proctored exam: Mar 4 (RPNow)
Faculty: T. Genova
No required text.
5505. Global Medical Device Regulation (990) crn: 51059 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
6:00 pm - 9:00 pm Tuesdays: Jan 16, 23, 30, Feb 6, 13, 20, 27, Mar 5, 12, 19, 26, Apr 2. Meets 12 times plus final exam. Make-ups, if needed, Apr 9 and 16.
Proctored exam: Feb 27 (RPNow)
Faculty: M. Arentz
No required text.
Not open to students who have completed RAQA 505.
5508. Good Pharmacovigilance Operations (990) crn: 53066 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
6:00 pm – 9:00 pm Mondays: Jan 22, 29, Feb 5, 12, 19 (Presidents’ Day), 26, Mar 4, 11, 18, 25, Apr 1, 15, 22. Meets 12 times plus final exam. No class Apr 8. Make-ups, if needed, Apr 29 and May 6.
Proctored final exam: Apr 22 (RPNow)
Faculty: L. Thomas
Required text: Colbert’s Manual of Drug Safety and Pharmacovigilance, Colbert, Gregory & Thomas, 3rd edition, World Scientific, ISBN: 9813278846 or 9789813278833. Do not purchase until you attend the first class.
5514. Regulatory eSubmissions (990) crn: 42720 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
Prerequisite: Drug Development (5459).
6:00 pm - 9:00 pm Wednesdays: Jan 17, 24, 31, Feb 7, 14, 21, 28, Mar 6, 13, 20, 27, Apr 3. Meets 12 times plus final exam. Make-ups, if needed, Apr 10 and 17.
Proctored exam: Feb 28 (RPNow)
Faculty: R. Arbaugh
No required text.
5536. Good Clinical Practices (990) crn: 51052 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
6:00 pm – 9:00 pm Tuesdays: Jan 16, 23, 30, Feb 6, 13, 20, 27, Mar 5, 12, 19, 26, Apr 2. Meets 12 times plus final exam. Make-ups, if needed, Apr 9 and 16.
Proctored exam: Feb 27 (RPNow)
Faculty: D. Weiss
No required text.
Not open to students who have completed RAQA 536.
5536. Good Clinical Practices (991) crn: 42932 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
6:00 pm – 9:00 pm Mondays: Jan 22, 29, Feb 5, 12, 19 (Presidents’ Day), 26, Mar 4, 11, 18, 25, Apr 1, 8. Meets 12 times plus final exam. Make-ups, if needed, Apr 15 and 22.
Proctored exam: Mar 4 (RPNow)
Faculty: J. Hayes
Required texts (Students will be required to choose one): 1) The Nazi Doctors and the Nuremberg Code; Annas and Grodin; OR, 2) Wonder Drug: The Secret History of Thalidomide in America and its Hidden Victims,
Vanderbes; OR, 3) Vaccinated: One Man's Quest to Defeat the World's Deadliest Diseases; P.A Offit, MD
Not open to students who have completed RAQA 536.
5537. Clinical Trial Management (990) crn: 20667 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
Prerequisite: Good Clinical Practices (5536). Students with clinical experience may ask to take the course but must include their resume with registration.
6:00 pm - 9:00 pm Mondays: Jan 22, 29, Feb 5, 12, 19 (Presidents’ Day), 26, Mar 4, 11, 18, 25, Apr 1, 8. Meets 12 times plus final exam. Make-ups, if needed, Apr 15 and 22.
Proctored exam: Mar 4 (RPNow)
Faculty: J. Scavone
No required text.
Not open to students who have completed RAQA 537.
5539. Global Clinical Drug Development (990) crn: 53068 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
6:00 pm – 9:00 pm Thursdays: Jan 18, 25, Feb 1, 8, 15, 22, 29, Mar 7, 14, 21, 28, Apr 4. Meets 12 times plus final exam. Make-ups, if needed, Apr 11 and 18.
Proctored exam: Feb 29 (RPNow)
Faculty: K. Weiss
No required text.
Not open to students who have completed RAQA 539.
5542. Pharmacopoeia Compliance: Understanding the Global Impact on RAQA (990) crn: 51037 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
Prerequisite: Drug Development (5459)
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 (RPNow)
Faculty: J. Albanese and M. Wiggins
No required text. (Readings will be posted on Canvas and available online.)
WEEKEND COURSE
5544. Regulatory Intelligence (990) crn: 51035 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course will use RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
Prerequisites: Drug Development (5459) and Food and Drug Law (5592).
9:00 am – 3:30 pm Sundays (1/2 hour lunch): Jan 14, 28, Feb 11, 25, Mar 10, 24. Meets 6 times plus final exam. Make-ups, if needed, Apr 7 and 14.
Proctored exam: Feb 25 (RPNow)
Faculty: L. Bowen
No required text.
5545. Post Approval Changes (PAC) (990) crn: 51047 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course will use RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
6:00 pm – 9:00 pm Thursdays: Jan 25, Feb 1, 8, 15, 22, 29, Mar 7, 14, 21, 28, Apr 4, 11. Meets 12 times plus final exam. Make-ups, if needed, Apr 18 and 25.
Proctored exam: Mar 7 (RPNow)
Faculty: K. Zimm
No required text.
Not open to students who have completed RAQA 545.
SIX WEEK SCHEDULE TWICE A WEEK
5571. Post Marketing Safety Surveillance (990) crn: 42724 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
6:00 pm - 9:00 pm Mondays and Wednesdays: Jan 17, 22, 24, 29, 31, Feb 5, 7, 12, 14, 19 (Presidents' Day), 21, 26. Meets 12 times plus final exam. Make-ups, if needed, Feb 28 and Mar 4.
Proctored exam: Feb 12 (RPNow)
Faculty: V. Patadia
Required text: Mann’s Pharmacovigilance, Author: Edited by Elizabeth B. Andrews, Nicholas Moore ISBN: 978-0-470-67104-7, Publisher: Wiley Blackwell Edition: 3rd Edition
Not open to students who have taken RAQA 571.
5572. Vaccines: RA and QA Issues (990) crn: 45613 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
This course has limited seats. If you wish to enroll, send in your registration form right away.
Prerequisite: Drug Development (5459). Students are also expected to have a college-level background in general biology and chemistry and some knowledge of general microbiology and/or immunology.
6:00 pm - 9:00 pm Mondays: Jan 22, 29, Feb 5, 12, 19 (Presidents’ Day), 26, Mar 4, 11, 18, 25, Apr 1, 8. Meets 12 times plus final exam. Make-ups, if needed, Apr 15 and 22.
Proctored exam: Feb 26 (RPNow)
Faculty: K. Surowitz
Required texts: Do not purchase texts until AFTER hearing discussion in the first class.
(1) Autism’s False Prophets, Paul Offit, 2008, Columbia University Press. Available in the Temple U Charles Library online.
(2) Epidemiology and Prevention of Vaccine Preventable Diseases, 13th edition, U.S. Centers for Disease Control (CDC). Students may download individual chapters for free or purchase the paperback from the CDC.
(3) The Challenge of CMC Regulatory Compliance for Biopharmaceuticals and other Biologics, John Geigert, 2nd edition, 2013, Springer. Available in the Temple U Charles Library online.
(4) Plotkin’s Vaccines, 7th edition, 2018, Plotkin, Orenstein, Offit, Edwards, editors, Elsevior. Available in the Temple U Charles Library online.
Not open to students who have completed RAQA 572.
5573. Pharmacoepidemiology (990) crn: 51062 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
6:00 pm – 9:30 pm Mondays: Jan 22, 29, Feb 5, 12, 19 (Presidents’ Day), 26, Mar 4, 11, 18, 25, Apr 1. Meets 10 times plus final exam. Make-ups, if needed, Apr 8 and 15.
Proctored exam: Apr 1 (RPNow)
Faculty: N. Cossrow
No required text.
Not open to students who have taken RAQA 570.
5574. Pharmaceutical Quality Management Systems (990) crn: 51029 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
Prerequisite: Drug Development (5459).
6:00 pm - 9:30 pm Tuesdays: Jan 23, 30, Feb 6, 13, 20, 27, Mar 5, 12 (recording), 26, Apr 2. Meets 10 times plus final exam. No class Mar 19. Make-ups, if needed, Apr 9 and 16.
Proctored exam: Feb 27 (RPNow)
Faculty: M. Labruto
Required text: Quality Systems and Control for Pharmaceuticals, Sarkar, Dipak, 2008 (ISBN: 978-0470056929).
5575. Regulatory Sciences: Managing the Guidelines for Quality (990) crn: 53069 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
Prerequisite: strong science background required. Forward resume to RAQA Office for approval.
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. Meets 12 times plus final exam. Make-ups, if needed, Apr 15 and 22.
Proctored exam: Mar 4 (RPNow)
Faculty: T. Schultz
No required text.
Not open to students who have completed RAQA 580.
5578. Risk Management and Safety Signaling of Healthcare Products (990) crn: 53070 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
Prerequisite: at least one course in Pharmacovigilance (5508, 5538, 5571, 5573, or 5579, or special permission of RAQA Office).
7:00 pm – 10:00 pm Thursdays: Jan 18, 25, Feb 1, 8, 15, 22, 29, Mar 7, 21, 28, Apr 4, 11. Meets 12 times plus final exam. No class Mar 14. Make-ups, if needed, Apr 18 and 25.
Proctored exam: Feb 29 (RPNow)
Faculty: J. Robinson
No required text.
5579. Regulatory and Legal Basis of Pharmacovigilance (990) crn: 53071 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
Prerequisite: Post Marketing Safety Surveillance (5571) OR Clinical Drug Safety and Pharmacovigilance (5538) or special permission (include resume).
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 (RPNow)
Faculty: K. Ward
Required text: Colbert’s Manual of Drug Safety and Pharmacovigilance, Colbert, Gregory & Thomas, 3rd edition, World Scientific, ISBN: 9813278846 or 9789813278833.
WEEKEND COURSE at Fort Washington - Special Note: if you prefer to take a course in a traditional classroom setting at Fort Washington, consider this course.
5591. Global Regulatory Affairs (101) crn: 53060
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.
5591. Global Regulatory Affairs (990) crn: 20671 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course is offered both on-campus at Ft Washington and online.
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
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.
Proctored exam: Feb 24 (RPNow)
Faculty: R. Phillips
No required text.
Not open to students who have completed RAQA 591.
DAYTIME ON-CAMPUS COURSE at Fort Washington - Special Note: If you prefer an on-campus section of Food and Drug Law, we are offering one at Ft Washington this spring:5592. Food and Drug Law (101) crn: 51042
2:00 pm - 5:30 pm Mondays: Jan 29, Feb 5, 12, 19 (Presidents’ 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.
5592. Food and Drug Law (990) crn: 9424 (ONLINE) Expectations of Online Students Registration Form for Online Courses - Note: Food and Drug Law will not be offered online in Summer 2024.
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
6:00 pm - 9:00 pm Wednesdays: Jan 17, 24, 31, Feb 7, 14, 21, 28, Mar 6, 13, 20, 27, Apr 3. Meets 12 times plus final exam. Make-ups, if needed, Apr 10 and 17.
Proctored exam: Feb 21 (RPNow)
Faculty: G. Pilgrim
Required text: Food and Drug Law: Cases and Materials, 5th edition, hard copy only, Hutt, et al, West Academic Publishing. Purchase the hard copy of the 5th edition. (Do not buy earlier editions or ebooks). 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 .
Not open to students who have completed RAQA 592.
5592. Food and Drug Law (991) crn: 25838 (ONLINE) Expectations of Online Students Registration Form for Online Courses - NOTE: Food and Drug Law will not be offered online in Summer 2024.
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
6:00 pm - 9:00 pm Tuesdays: Jan 16, 23, 30, Feb 6, 13, 20, 27, Mar 5, 12, 19, 26, Apr 2. Meets 12 times plus final exam. Make-ups, if needed, Apr 9 and 16.
Proctored exam: Feb 20 (RPNow)
Faculty: G. Pilgrim
Required text: Food and Drug Law: Cases and Materials, 5th edition, hard copy only, Hutt, et al, West Academic Publishing. Purchase the hard copy of the 5th edition. Do not buy earlier editions or ebooks. 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 .
Not open to students who have completed RAQA 592.
5594. Nutritional Supplements and Functional Foods (990) crn: 42729 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
6:00 pm - 9:00 pm Wednesdays: Jan 17, 24, 31, Feb 7, 14, 21, 28, Mar 6, 13, 20, 27, Apr 3. Meets 12 times plus final exam. Make-ups, if needed, Apr 10 and 17.
Proctored exam: to be announced (RPNow)
Faculty: D. Schoneker
No required text.
Not open to students who have completed RAQA 594.
5597. Food Good Manufacturing Practices (990) crn: 51045 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
6:00 pm - 9:30 pm Mondays: Jan 22, 29, Feb 5, 12, 19 (Presidents' Day), Mar 11, 18, Apr 1, 8, 15, 22. Meets 10 times plus final exam. No class Feb 26, Mar 4, or Mar 25. Make-up, if needed, Apr 29.
Proctored exam: Apr 22 (RPNow)
Faculty: M. Noonan
No required text.
5611. Regulation of Advertising & Promotions (990) crn: 51038 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
6:00 pm - 9:00 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 (RPNow)
Faculty: D. Cooke
Required texts: 1) Promotion of FDA-Regulated Medical Products, J. Hawana, B. Hills, B. Zegarellli, 2019; and 2) Effective Review and Approval of Digital Promotional Tactics, 2nd edition, Cooke, Dale, 2017.
Not open to students who have completed RAQA 611.
5612. Bioethics for Pharmaceutical Professionals (990) crn: 28699 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
6:00 pm – 9:00 pm Wednesdays: Jan 17, 24, 31, Feb 7, 14, 21, 28, Mar 6, 13, 20, 27, Apr 3. Meets 12 times plus final exam. Make-ups, if needed, Apr 10 and 17.
Proctored exam: Feb 28 (RPNow)
Faculty: D. Walsh
Required text: Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary, Emanuel, Crouch, Arras, Moreno and Grady, Johns Hopkins University Press, 2003.
Not open to students who completed RAQA 512.
5615. Project Management for Pharmaceutical Professionals (990) crn: 31575 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
Prerequisite: at least four courses in the RAQA program, including Drug Development (5459) and Food and Drug Law (5592).
6:00 pm - 9:00 pm Mondays: Jan 22, 29, Feb 5, 12, 19 (Presidents' Day), 26, Mar 4, 11, 18, 25, Apr 1, 8. Meets 12 times plus final exam. Make-ups, if needed, Apr 15 and 22.
Proctored exam: Feb 19 (RPNow)
Faculty: J. Sheldon
Recommended text: Project Management for the Pharmaceutical Industry, June 2011, revised reprint. Available online thought the Temple University Charles Library.
Not open to students who have taken 5547: Project Management for Clinical Trials.
LATE AFTERNOON COURSE at Fort Washington (description below) - This is an on-campus course ONLY this semester.
5650. Pharmaceutical Regulatory Leadership (101) crn: 53077
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.
Course 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.
5650. Critical Analysis of Media Coverage of the Pharmaceutical Industry (990) crn: 45587 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course has limited enrollment. If you wish to enroll, make sure you forward your registration form early.
6:00 pm – 9:00 pm Tuesdays: Jan 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.
Faculty: K. Zimm
Required text: Bottle of Lies, Egan. Purchase online: https://www.amazon.com/Bottle-Lies-Inside-Story-Generic/dp0062338781. Also available through the Temple U Charles Library.
PHARMACEUTICAL SCIENCE COURSE – strong science background required
WEEKEND COURSE
8005. Pharmaceutical Biotechnology (990) crn: 51044 (ONLINE) Expectations of Online Students Registration Form for Online Courses
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.
8:30 am - 3:00 pm Saturdays (1/2 hour lunch): Jan 20, Feb 3, 17, Mar 2, 16, Apr 6, 20. Meets 6 times plus final exam. Make-up, if needed, Apr 27.
Proctored exams: Mar 2 and Apr 20 via Zoom
Faculty: T. Parry
Required text: Pharmaceutical Biotechnology: Fundamentals and Applications, Crommelin, Sindelar & Meibohm, editors, 3rd edition, Informa Healthcare 2007 (ISBN 10: 1420044370), ISBN 13 978 1420044379). Paperback recommended. Suggested: Biopharmaceutical: Biochemistry and Biotechnology, Walsh, G., 2nd edition, (ISBN 0 470 84327 6), available online. Students should have access to textbooks in biochemistry and/or molecular biology.
Not open to students who have completed Pharmaceutics 475.
EVENING COURSE at Fort Washington
8006. Physical Pharmacy (101) crn: 53089 - You may take this course on-campus 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.
8006. Physical Pharmacy (990) crn: 53075 (ONLINE) Expectations of Online Students Registration Form for Online Courses
Special note: this course is only offered every other spring semester. The next time it will be scheduled is Spring 2026, so if this course is required for your degree, please plan accordingly.
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
This course is offered both at Fort Washington and online.
Prerequisite: A strong science and math background, including 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 (RPNow)
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
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.
8007. Applied Pharmaceutics (990) crn: 53076 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the exam.
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 (RPNow)
Faculty: R. Fassihi
No required text.
Not open to students who have completed Pharmaceutics 410.