Spring 2025 Schedule for the RAQA Graduate Program  (Updated: December 19, 2024)

All courses are listed in numerical order in East Coast Time (remember to adjust class start times to your time zone)

Registration Form for Online Courses

Expectations of Online Students

Spring 2025 Schedule pdf

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 Jessie Chen (jessie.chen@temple.edu) or David Brickett ([click-for-email]) to review how Zoom works, so you'll be ready for your first online class meeting.

Proctorio is an online proctoring service, which enables you to take exams at almost any location. If a course uses Proctorio, all students in the class must use that service. 

Proctorio 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 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 for an initial makeup exam; $50 for the second missed exam, and $100 per exam thereafter. For more on this policy, click here.

NEW COURSE THIS SPRING  (courses are listed numerically, so scroll down to learn their dates, times, and instructors: 

5650. Artificial Intelligence/Machine Leaning - Medical Devices (991) (ONLINE)  (see details below)

5650. Pharmaceutical Regulatory Leadership (On-Campus Course at RAQA's Fort Washington Location)

FULL SCHEDULE OF SPRING 2025 COURSES

5000.  KENX Conference 1.5 credit hours Expectations of Online Students   Registration Form for Online Courses
Did you know that you can earn 1.5 credits towards the MS in RAQA by attending a KENX Conference on Validation & Qualification Processes in Philadelphia between March 26 and 27? You must attend or watch all sessions marked “Temple Track,” then take a proctored open-book final exam within 6 weeks. For more detailed information on conference topics and locations, visit kenx.org/conferences. 

5459. Drug Development (990) crn: 42713 (ONLINE) Expectations of Online Students   Registration Form for Online Courses   
This course uses Proctorio online proctoring.
6:00 pm - 9:00 pm Thursdays: Jan 23, 30, Feb 6, 13, 20, 27, Mar 6, 13, 20, 27, Apr 3, 10. Meets 12 times plus final exam.  Make-ups, if needed, Apr 17 (Passover) and 24.
Proctored exam: Mar 6 (Proctorio)
Faculty: C. Ciliberto
Suggested text: Drugs: From Discovery to Approval, Ng, 3^rd edition, 2015 (ISBN-13:978-1118907276 or ISBN-10: 1118907272).
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 Proctorio online proctoring.
6:00 pm - 9:00 pm Wednesdays: Jan 22, 29, Feb 5, 12, 19, 26, Mar 5, 12, 19, 26, Apr 2, 9. Meets 12 times plus final exam. Make-ups, if needed, Apr 16 (Passover) and 23.
Proctored exam:  Mar 5 (Proctorio)
Faculty:  J. Hayes
Required text: Drugs, From Discovery to Approval, 3rd edition, Rick Ng, ISBN-13:978-1118907276 or ISBN-10: 1118907272.
In addition, students will be required to choose one of the following texts and write a book review: 1. Ten Drugs, Hager, ISBN: 13-97: 1419735226; 2. For Blood and Money: Billionaires, Biotech, and the Quest for a Blockbuster Drug; Vardi; ISBN-13:‎ 978-0393540956; 3. Making Medicine: Surprising Stories from the History of Drug Discovery, hardcover – July  2022; Veronese; ISBN-13:‎ 978-1633887534.
Not open to students who have completed RAQA 459.

WEEKEND COURSE
5459. Drug Development (992) crn: 51026 (ONLINE) Expectations of Online Students   Registration Form for Online Courses
This course uses Proctorio online proctoring. . 
10:00 am – 1:00 pm Saturdays: Jan 18, 25, Feb 1, 8, 15, 22, Mar 1, 8, 15, 22, 29, Apr 5. Meets 12 times plus final exam.  Make-ups, if needed, Apr 12 and 19 (Passover).
Proctored exam:  Mar 1 (Proctorio)
Faculty:  D. Walsh
Required texts: 1) Drugs: From Discovery to Approval, Ng, 3^rd 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.

5477. Good Manufacturing Practices (990) crn: 3439 (ONLINE) Expectations of Online Students   Registration Form for Online Courses
This course uses Proctorio online proctoring. 
6:00 pm - 9:30 pm Thursdays: Jan 23, Feb 6, 13, 20, 27, Mar 6, 13, 20, 27, Apr 3, 10. Meets 10 times plus final exam. No class Jan 30. Make-ups, if needed, Apr 24 and May 1.
Proctored exam: Apr 10 (Proctorio)
Faculty: M. Noonan
No required text.
Not open to students who have completed RAQA 487.

5477. Good Manufacturing Practices (991) crn:  55325 (ONLINE) Expectations of Online Students   Registration Form for Online Courses
This course uses Proctorio online proctoring.   
6:00 pm – 9:00 pm Tuesdays: Jan 21, 28, Feb 4, 11, 18, 25, Mar 4, 11, 18, 25, Apr 1, 8. Meets 12 times plus final exam. Make-ups, if needed, Apr 15 (Passover) and 22.
Proctored exam: Feb 25 (Proctorio)
Faculty: R. Phillips
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 Proctorio online proctoring.
Prerequisite: strong science background. Submit resume with registration.
6:00 pm - 9:00 pm Mondays: Jan 27, Feb 3, 10, 17 (Presidents’ Day), 24, Mar 3, 10, 17, 24, 31, Apr 7, 14 (Passover), 21.  Meets 12 times plus final exam. Make-up, if needed, Apr 28 and May 5.
Proctored exam: Apr 21 (Proctorio) 
Faculty: D. Casaburi
Required text: Validation of Pharmaceutical Processes, 3^rd 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 Proctorio online proctoring.
Prerequisite: a good practices course: GLPs (5476), GMPs (5477), Advanced GMPs (5479), or GCPs (5536).
7:00 pm - 10:00 pm Tuesdays: Jan 21, 28, Feb 4, 11, 18, 25, Mar 4, 11, 18, 25, Apr 1, 8, 15 (Passover). Meets 12 times plus final exam. Make-ups, if needed, Apr 22 and 29.
Proctored exam: ​​​​​​ Apr 15 (Proctorio)
Faculty: J. Werrmann
Required text: The ASQ Certified Quality Auditor, 5^th 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 5^th 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 Proctorio online proctoring.
Prerequisite: Drug Development (5459) or Food and Drug Law (5592).
6:00 pm – 9:00 pm Mondays: Jan 27, Feb 3, 10, 17 (Presidents’ Day), 24, Mar 3, 10, 17, 24, 31, Apr 7, 14 (Passover).  Meets 12 times plus final exam. Make-ups, if needed, Apr 21 and 28.
Proctored exam: Mar 10 (Proctorio)
Faculty: A. Smith
Required text: New Drug Development: A Regulatory Overview, Mathieu, 8^th revised edition. 
Not open to students who have 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 Proctorio online proctoring.
Prerequisite: Drug Development (5459) or Food and Drug Law (5592).
8:30 am – 2:00 pm Saturdays:  Jan 18, Feb 1, 15, Mar 1, 15, 29, Apr 12. Meets 7 times plus final exam.  Make-up, if needed, Apr 26.
Proctored exam: Mar 1 (Proctorio)
Faculty: P. Smith
Required text: New Drug Development: A Regulatory Overview, Mathieu, 8^th revised edition. 
Not open to students who have completed RAQA 495.

5501. Development of Sterile Products (990) crn: 55322 (ONLINE) Expectations of Online Students   Registration Form for Online Courses
This course uses Proctorio online proctoring.  
Prerequisite: a minimum of 2 years of general chemistry, including one organic and one analytical chemistry course. RAQA students must include their resume for written permission to register.
6:00 pm - 9:00 pm Wednesdays: Jan 22, 29, Feb 5, 12, 19, 26, Mar 5, 12, 19, 26, Apr 2, 9, 16 (Passover).  Meets 12 times plus final exam.  Make-ups, if needed, Apr 23 and 30.
Proctored exam: Apr 16 (Proctorio)
Faculty: D. Casaburi
No required text:
Not open to students who have completed RAQA 501.

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 Proctorio online proctoring.
6:00 pm - 9:00 pm Tuesdays:  Jan 21, 28, Feb 4, 11, 18, 25, Mar 4, 11, 18, 25, Apr 1, 8. Meets 12 times plus final exam. Make-ups, if needed, Apr 15 (Passover) and 22
Proctored exam: Mar 4 (Proctorio)
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 Proctorio online proctoring. 
6:00 pm – 9:00 pm Mondays: Jan 27, Feb 3, 10, 17 (Presidents’ Day), 24, Mar 3, 10, 17, 24, 31, Apr 7, 14 (Passover). Meets 12 times plus final exam. Make-ups, if needed, Apr 21 and 28.
Proctored exam: Mar 10. (Proctorio)
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 Proctorio online proctoring.
6:00 pm - 9:00 pm Wednesdays: Jan 22, 29, Feb 5, 12, 19, 26, Mar 5, 12, 19, 26, Apr 2, 16 (Passover), 23. Meets 12 times plus final exam. No class April 9. Make-up, if needed, Apr 30 and May 7.
Proctored exam: Apr 23 (Proctorio)
Faculty: L. Thomas
Required text: Colbert’s Manual of Drug Safety and Pharmacovigilance, Colbert, Gregory & Thomas, 3^rd edition, World Scientific, ISBN: 9813278846 or 9789813278833.

5509. Pediatric and Orphan Drug Regulations (990) 55323 (ONLINE) Expectations of Online Students   Registration Form for Online Courses
This course uses Proctorio online proctoring.
6:00 pm - 9:00 pm Thursdays: Jan 23, 30, Feb 6, 13, 20, 27, Mar 6, 13, 20, 27, Apr 3, 10. Meets 12 times plus final exam.  Make-ups, if needed, Apr 17 (Passover) and 24.
Proctored exam:  Mar 6 (Proctorio)
Faculty:  K. Weiss
No required text.

5512. Microbiological Concepts in Pharmaceutical Manufacturing (990) crn: 55321 (ONLINE)  Expectations of Online Students   Registration Form for Online Courses This course uses Proctorio online proctoring.
Prerequisite: strong science background.  Attach resume with registration form.
6:00 pm – 9:00 pm Thursdays: Jan 23, 30, Feb 6, 13, 20, 27, Mar 6, 13, 20, 27, Apr 3, 10.  Meets 12 times plus final exam.  Make-ups, if needed, Apr 17 (Passover) and 24.
Proctored exam: Mar 13 (Proctorio)
Faculty: R. Saha.
No required text. All readings available on the Internet.
Not open to students who have completed RAQA 512.

5514. Regulatory eSubmissions (990) crn: 42720 (ONLINE) Expectations of Online Students   Registration Form for Online Courses
This course uses Proctorio online proctoring. 
Prerequisite: Drug Development (5459) and IND/NDA Submissions (5495) or submit resume indicating industry experience for special permission to register. .
6:00 pm - 9:00 pm Wednesdays: Jan 22, 29, Feb 5, 12, 19, 26, Mar 5, 12, 19, 26, Apr 2, 9. Meets 12 times plus final exam. Make-ups, if needed, Apr 16 (Passover) and 23.
Proctored exam: Mar 5 (Proctorio)
Faculty: R. Arbaugh
No required text.

5536. Good Clinical Practices (101) crn: 55326 - There is an on-campus section of GCPs on Tuesdays at Fort Washington.  See the On-Campus Schedule for details.

5536. Good Clinical Practices (990) crn: 51052 (ONLINE) Expectations of Online Students   Registration Form for Online Courses
This course uses Proctorio online proctoring.
6:00 pm - 9:00 pm Mondays: Jan 27, Feb 3, 10, 17 (Presidents’ Day), 24, Mar 3, 10, 17, 24, 31, Apr 7, 14 (Passover). Meets 12 times plus final exam. Make-ups, if needed, Apr 21 and 28.
Proctored exam: ​​Mar 10 (Proctorio)
Faculty:  J. Hayes
No required text.
Optional texts (Do not purchase before the class meets!): 1. The Autumn Ghost: How the Battle Against a Polio Epidemic Revolutionized Modern Medical Care; H. Wunsch; ISBN-13:‎ 978-1771649452; 3. The Breakthrough: Immunotherapy and the Race to Cure Cancer; C. Graeber; ISBN-13:‎ 978-1455568505; 3. Frances Oldham Kelsey, the FDA, and the Battle against Thalidomide; C.K. Warsh; ISBN-13:‎ 978-0197632543
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 Proctorio online
proctoring.
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 Wednesdays: Jan 22, 29, Feb 5, 12, 19, 26, Mar 5, 12, 19, 26, Apr 2, 9. Meets 12 times plus final exam. Make-ups, if needed, Apr 16 (Passover) and 23.
Proctored exam: Mar 5 (Proctorio)
Faculty: J. Scavone
No required text.
Not open to students who have completed RAQA 537.

5538. Clinical Drug Safety and Pharmacovigilance (online)  Expectations of Online Students   Registration Form for Online Courses
This course uses Proctorio online proctoring.
Prerequisite: Good Clinical Practices (5536) or appropriate experience in industry GCPs.
5:30 pm - 8:30 pm Mondays: Jan 27, Feb 3, 10, 17 (Presidents’ Day), 24, Mar 3, 10, 17, 24, 31, Apr 7, 14 (Passover), 21. Meets 12 times plus final exam. Make-up, if needed, Apr 28 and May 5.
Proctored final exam: April 21
Faculty: C. Baldridge
Required text: Cobert’s Manual of Drug Safety and Pharmacovigilance, 4^th Edition only, Feb 2025, Cobert, Gregory, Thomas, Baldridge: https://www.worldscientific.com/worldscibooks/10.1142/13970#t=aboutBook

WEEKEND COURSE
5544. Regulatory Intelligence (990) crn: 51035 (ONLINE) Expectations of Online Students   Registration Form for Online Courses
This course uses Proctorio online proctoring.
Prerequisites: Drug Development (5459) and Food and Drug Law (5592).
9:00 am – 3:30 pm Sundays (1/2 hour lunch): Jan 19, Feb 2, 16, Mar 2, 16, 30.  Meets 6 times plus final exam. Make-ups, if needed, Apr 13 and 27.
Proctored exam:  Mar 2 (Proctorio)
Faculty:  L. Bowen
No required text.

5572. Vaccines: RA and QA Issues (990) crn: 45613 (ONLINE) Expectations of Online Students   Registration Form for Online Courses
This course uses Proctorio online proctoring.
This course has limited seats. 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 Thursdays:  Jan 23, 30, Feb 6, 13, 20, 27, Mar 6, 13 (recording), 20, 27, Apr 3, 10. Meets 12 times plus final exam. Make-ups, if needed, Apr 17 (Passover) and 24.
Proctored exam: Feb 27 (Proctorio) 
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, 13^th 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, 3rd edition, 2019, Springer. Available in the Temple U Charles Library online. (4) Plotkin’s Vaccines, 7^th 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 Proctorio online proctoring.
6:00 pm - 9:30 pm Mondays: Jan 27, Feb 3, 10, 17 (Presidents’ Day), 24, Mar 3, 10, 17, 24,31,  Apr 7. Meets 10 times plus final exam. Make-ups, if needed, Apr 14 (Passover) and 21.
Proctored exam: Apr 7 (Proctorio)
Faculty:  N. Cossrow
No required text.

5574. Quality Management Systems (990) crn: 51029 (ONLINE) Expectations of Online Students   Registration Form for Online Courses
This course uses Proctorio online proctoring.
Prerequisite: Drug Development (5459)
6:00 pm – 9:30 pm Mondays:  Jan 27, Feb 3, 10, 17 (Presidents’ Day), 24 (recording), Mar 3, 10, 17, 24, Apr 7. Meets 10 times plus final exam. No class Mar 31 Make-ups, if needed, Apr 14 (Passover) and 21.
Proctored exam: Mar 3 (Proctorio).
Faculty: M. LaBruto
No required text.

5575. Regulatory Sciences:  Managing the Guidelines for Quality (990) crn: 53069 (ONLINE) Expectations of Online Students   Registration Form for Online Courses
This course uses Proctorio online proctoring. 
Prerequisite: strong science background required.  Include resume with registration for approval.
5:30 pm – 8:30 pm Tuesdays: Jan 21, 28, Feb 4, 11, 18, 25, Mar 4, 11, 18,  25, Apr 1, 8. Meets 12 times plus final exam. Make-ups, if needed, Apr 15 (Passover) and 22.
Proctored exam:  Mar 4 (Proctorio)
Faculty: T. Schultz
No required text.
Not open to students who have completed RAQA 580.

5577. Global CMCs – Biopharmaceuticals and Other Biologics (990) crn: 55328 (ONLINE) Expectations of Online Students   Registration Form for Online Courses
This course uses Proctorio online proctoring. 
6:00 pm - 9:00 pm Tuesdays: Jan 21, 28, Feb 4, 11, 18, 25, Mar 4, 11, 18, 25, Apr 1, 8. Meets 12 times plus final exam. Make-ups, if needed, Apr 15 (Passover) and 22.
Proctored exam:  Feb 25 (Proctorio)
Faculty: J. Quinn
Required text: The Challenge of CMC Regulatory Compliance for Biopharmaceuticals, J. Geigert, 2024 https://link.springer.com/book/10.1007/978-3-031-31909-9

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 Proctorio online proctoring.
Prerequisite: Clinical Drug Safety and Pharmacovigilance (5538) or Post Marketing Safety Surveillance (5571).
7:00 pm - 10:00 pm Thursdays:  Jan 23, 30, Feb 6, 13, 20, 27, Mar 6, 13, 20, 27, Apr 3, 10, 17 (Passover). Meets 12 times plus final exam. Make-ups, if needed, Apr 24 and May 1.
Proctored exam: Apr 17 (Proctorio)
Faculty:  J. Robinson
No required text.

5591. Global Regulatory Affairs (990) crn: 20671 (ONLINE) Expectations of Online Students   Registration Form for Online Courses
This course uses Proctorio online proctoring. 
Prerequisite: Drug Development (5459) or Food and Drug Law (5592).
6:00 pm – 9:00 pm Mondays:  Jan 27, Feb 3, 10, 17 (Presidents’ Day), 24, Mar 3, 10, 17, 24, 31, Apr 7, 14 (Passover). Meets 12 times plus final exam. Make-ups, if needed, Apr 21 and 28.
Proctored exam: Mar 3 (Proctorio)
Faculty: D. Larkins
No required text.
Not open to students who have completed RAQA 591.

5592. Food and Drug Law (101) crn:  51042 - There is an on-campus section of Food and Drug Law on Wednesdays at Ft Washington.  See the On-Campus Schedule for details.

5592. Food and Drug Law (990) crn: 9424 (ONLINE) Expectations of Online Students   Registration Form for Online Courses
This course uses Proctorio online proctoring.
Special note: Dr. Pilgrim will not be teaching this summer.  If you wish to take this course with her, sign up for Spring or Fall 2025.
6:00 pm - 9:00 pm Wednesdays: Jan 22, 29, Feb 5, 12, 19, 26, Mar 5, 12, 19, 26, Apr 2, 9. Meets 12 times plus final exam. Make-ups, if needed, Apr 16 (Passover) and 23.
Proctored exam: Mar 5 (Proctorio)
Faculty: G. Pilgrim
Required text: Food and Drug Law: Cases and Materials, 5^th edition, hard copy only, Hutt, et al, West Academic Publishing. Purchase the hard copy of the 5^th edition. Do not buy earlier editions or eBooks.
West Academic Publishing gives a 15% discount and free ground shipping to students for 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
This course uses Proctorio online proctoring.
Special note: Dr. Pilgrim will not be teaching this summer.  If you wish to take this course with her, sign up for this Spring or Fall 2025.
6:00 pm - 9:00 pm Tuesdays: Jan 21, 28, Feb 4, 11, 18, 25, Mar 4, 11, 18, 25, Apr 1, 8. Meets 12 times plus final exam. Make-ups, if needed, Apr 15 (Passover) and 22.
Proctored exam: Mar 4 (Proctorio)
Faculty: G. Pilgrim
Required text: Food and Drug Law: Cases and Materials, 5^th edition, hard copy only, Hutt, et al, West Academic Publishing. Purchase the hard copy of the 5^th edition. Do not buy earlier editions or eBooks.
West Academic Publishing gives a 15% discount and free ground shipping to students for 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. Regulation of Dietary Supplements and Functional Food (990) crn: 42729 (ONLINE) Expectations of Online Students   Registration Form for Online Courses
This course uses Proctorio online proctoring.
6:00 pm – 9:00 pm Wednesdays: Jan 22, 29, Feb 5, 12, 19, 26 (recording), Mar 5, 12, 19, 26, Apr 2, 9. Meets 12 times plus final exam. Make-ups, if needed, Apr 16 (Passover) and 23.
Proctored exam: Mar 5 (Proctorio)
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 Proctorio online proctoring. 
6:00 pm – 9:30 pm Mondays: Feb 3, 10, 17 (Presidents’ Day), 24, Mar 3, 10, 17, 24, 31, Apr 7, 21. Meets 10 times plus final exam. No class Jan 27 or Apr 14. Make-ups, if needed, Apr 28 and May 5.
Proctored exam: Apr 21 (Proctorio)
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 Proctorio online proctoring.
6:00 pm – 9:00 pm Tuesdays: Jan 21, 28, Feb 4, 11, 18, 25, Mar 4, 11, 18, 25, Apr 1, 8, 15 (Passover). Meets 12 times plus final exam.  Make-ups if needed, Apr 22 and 29.
Proctored exam: Apr 15 (Proctorio)
Faculty: D. Cooke
Required text: 1) Promotion of FDA-Regulated Medical Products, J. Hawana, B. Hills, B. Zegarelli, 2019; and 2) Effective Review and Approval of Digital Promotional Tactics, 2^nd 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 Proctorio online proctoring.
6:00 pm – 9:00 pm Thursdays: Jan 23, 30, Feb 6, 13, 20, 27, Mar 6, 13, 20, 27, Apr 3, 10.  Meets 12 times plus final exam. Make-ups, if needed, Apr 17 (Passover) and 24.
Proctored exam: Mar 6 (Proctorio) 
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 Proctorio online proctoring. 
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 27, Feb 3, 10, 17 (Presidents' Day), 24, Mar 3, 10, 17, 24, 31, Apr 7, 14 (Passover).  Meets 12 times plus final exam.  Make-ups, if needed, Apr 21 and 28.
Proctored exam: Mar 3 (Proctorio)
Faculty:  J. Sheldon
Not open to students who have completed RAQA 615 or RAQA 5547 - Project Management for Clinical Trials).

5650. Pharmaceutical Regulatory Leadership (101) crn: 56676 (ON-CAMPUS COURSE) - there is an on-campus section of Pharmaceutical Regulatory Leadership that meets on Thursdays.  See the On-Campus Schedule for more details.

5650.  Critical Analysis of Media Coverage of the Pharmaceutical Industry (990) crn: 45587 (ONLINE)
To learn more:  https://raqa-sierra.temple.edu/PVideos/RAQA5650.mp4  
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 21, 28, Feb 4, 11, 18, 25, Mar 4, 11, 18, 25, Apr 1, 8. Meets 12 times plus final exam. Make-ups, if needed, Apr 15 (Passover) and 22.
Faculty: K. Zimm
Required text: Bottle of Lies, Eban. Purchase online. Also available through the Temple U Charles Library.

5650. Special Topics: Regulation of Artificial Intelligence & Machine Learning (AI/ML) Medical Devices (991) crn:  55327 (ONLINE)  Expectations of Online Students   Registration Form for Online Courses
This course uses Proctorio online proctoring. 
Prerequisites Drug Development (5459) OR Food and Drug Law (5592).
Suggested prerequisites (NOT required): Regulation of Medical Devices: Submissions (5502) and/or IND/NDA Submissions (5459).
6:00 pm - 9:00 pm Tuesdays: Jan 21, 28, Feb 4, 11, 18, 25, Mar 4, 11, 18, 25, Apr 1, 8, 15 (Passover).  Meets 12 times plus final exam.  Make-ups, if needed, Apr 22 and 29. Proctored exam: Apr 15 (Proctorio)
Faculty:  C. Kuehn and K. Fuh
No required text.

PHARMACEUTICAL SCIENCE COURSE - strong science background required

8004. Solid Dosage Forms – Small Molecules (990) crn: 55324 (ONLINE) Expectations of Online Students   Registration Form for Online Courses
This course uses Proctorio online proctoring. 
Prerequisite: Strong science background, including a degree in pharmacy, chemistry, biochemistry, biology, or chemical engineering. RAQA students must include resume with registration form.
6:00 pm - 9:00 pm Wednesdays: Jan 22, 29, Feb 5, 12, 19, 26, Mar 5, 12, 19, 26, Apr 2, 9. Meets 12 times plus final exam.  Make-ups, if needed, Apr 16 (Passover) and 23.
Proctored exam:  Mar 5 (Proctorio)
Faculty:  K. Zimm
No required text.
Not open to students who have completed Pharmaceutics 407.

PHARMACEUTICAL SCIENCE COURSE - strong science background required
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 permission to register.
6:00 pm – 9:00 pm Thursdays: Jan 23, 30, Feb 6, 13, 20, 27, Mar 6, 13, 20, 27, Apr 3, 10, 17 (Passover). Meets 12 times plus final exam. Make-up, if needed, Apr 24 and May 1.
Proctored exams: Mar 6 and Apr 17 (proctored through Zoom)
Faculty:  T. Parry
Required text: Pharmaceutical Biotechnology: Fundamentals and Applications, Crommelin, Sindelar & Meibohm, editors, any of the 3rd through 6^th editions should be ordered, 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.

Expectations of Online Students 

Registration Form for Online Courses