Fall 2023 Schedule of Online Courses (Interactive Courses in Real Time)

Fall 2023 Schedule for the RAQA Graduate Program (Updated: August 20, 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

PDF of all Fall Courses (On-Campus and Online)

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 (dbrick@temple.edu) or Mike Doukas (mdoukas@temple.edu) 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 either 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. Topics this fall semester include:

Cleaning University, still available online https://kenx.org/conferences/cleaning-validation-critical-processes-cleaning-university/
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.
5000 (990) crn: 49580 – virtual

GMP University, still available online https://kenx.org/conferences/gmp-university-2023/
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.
5000 (991) crn: 54374 – virtual

Medical Device Validation & Compliance, Oct 24-26, San Diego, CA or virtual https://kenx.org/conferences/medical-device-vv-university/
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.
5000 (009) crn: 54387 – in person (San Diego)
5000 (992) crn: 49581 - virtual

Coming Spring Semester 2024 (between the fall & spring semesters): CSV & Software Assurance, Dec 5-7, San Diego, CA or virtual: https://kenx.org/conferences/2023-computer-systems-validation-software-assurance-university/

JUST ADDED!
5495. IND/NDA Submissions (992) crn: 54616 (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 proctored exam.
Prerequisite: Drug Development (5459) or Food and Drug Law (5592).
8:30 am - 2:00 pm Saturdays (1/2 hour lunch): Sept 16 (Rosh Hashanah), 30, Oct 14, 28, Nov 11, Dec 2, 9. Class meets 7 times plus final exam. Make-up, if needed, Dec 16.
Proctored exam: Oct 28 (RPNow
Faculty: P. Smith
Not open to students who completed RAQA

5459. Drug Development (990) crn: 17910 (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 proctored exam.
6:00 pm - 9:00 pm Thursdays: Sept 14, 21, 28, Oct 5, 12, 19, 26, Nov 2, 9, 16, 30, Dec 7. Meets 12 times plus final exam. No class Nov 23 (Thanksgiving). Make-ups, if needed, Dec 14 and 21.
Proctored exam: Oct 26 (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: 7407 (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 proctored exam.
6:00 pm - 9:00 pm Mondays: Sept 11, 18, 25 (Yom Kippur), Oct 2, 9 (Columbus Day), 16, 23, 30, Nov 6, 13, 27, Dec 4. Meets 12 times plus final exam. No class Nov 20. Make-ups, if needed, Dec 11 and 18.
Proctored exam: Oct 23 (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 three 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, Sep 2019, Deborah Blum OR
2) The Jungle, Paperback, 2019, Upton Sinclair or
3) The Great Influenza: The Story of the Deadliest Pandemic in History Paperback – Oct 2005, John M. Barry
Not open to students who have completed RAQA 459.

5459. Drug Development (992) crn: 28608 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course will use PSI Services LLC’s RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to PSI via credit card at the start of the proctored exam.
6:00 pm - 9:00 pm Wednesdays: Sept 13, 20, 27, Oct 4, 11, 18, 25, Nov 1, 8, 15, 29, Dec 6. Meets 12 times plus final exam. No class Nov 22. Make-ups, if needed, Dec 13 and 20.
Proctored exam: Oct 25 (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 three 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, Sep 2019, Deborah Blum OR
2) The Jungle, Paperback, 2019, Upton Sinclair or
3) The Great Influenza: The Story of the Deadliest Pandemic in History Paperback – Oct 2005, John M. Barry
Not open to students who have completed RAQA 459.

WEEKEND COURSE
5459. Drug Development (993) crn: 46247 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course will use PSI Services LLC’s RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to PSI via credit card at the start of the proctored exam.
8:30 am - 2:00 pm Saturdays (1/2 hour lunch): Sept 16 (Rosh Hashanah), 30, Oct 14, 28, Nov 11, Dec 2, 9. Class meets 7 times plus final exam. Make-up, if needed, Dec 16.
Proctored exam: Oct 28 (RPNow)
Faculty: P. Smith
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.
Special Note: There is also an on-campus section of Drug Development. See the On-Campus Schedule for information.

5474. Process Validation (990) crn: 54364 (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 proctored exam
Prerequisites: Strong science background, such as a (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: Sept 14, 21, 28, Oct 5, , 19, 26, Nov 2, 9, 16, 30, Dec 7. Meets 12 times plus final exam. No class Nov 23 (Thanksgiving). Make-ups, if needed, Dec 14 and 21.
Proctored exam: Oct 26 (RPNow)
Faculty: K. BarnthouseRequired 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.

5476. Good Laboratory Practices (990) crn: 54365 (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 proctored exam.
6:00 pm - 9:00 pm Wednesdays: Sept 13, 20, 27, Oct 4, 11, 18, 25, Nov 1, 8, 15, 29, Dec 6. Meets 12 times plus final exam. No class Nov 22. Make-ups, if needed, Dec 13 and 20.
Proctored exam: Oct 25 (RPNow)
Faculty: S. Wilson.
No required text.
Not open to students who have completed RAQA 486.

5477. Good Manufacturing Practices (990) crn: 9357 (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 proctored exam.
6:15 pm - 9:30 pm Thursdays: Sept 14, 21, 28, Oct 5, 12, 19, Nov 2, 9, 16, 30, Dec 7, 14. Meets 11 times plus final exam. No class Oct 26 or Nov 23 (Thanksgiving). Make-up, if needed, Dec 21.
Proctored exam: Dec 14 (RPNow)
Faculty: M. Noonan
No required text.
Not open to students who have completed RAQA 487.

5477. Good Manufacturing Practices (991) crn: 34740 (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 proctored exam.
6:00 pm - 9:00 pm Mondays: Sept 11, 18, 25 (Yom Kippur), Oct 2, 9 (Columbus Day), 16, 23, 30, Nov 6, 13, 27, Dec 4. Meets 12 times plus final exam. No class Nov 20. Make-ups, if needed, Dec 11 and 18.
Proctored exam: Oct 26 (RPNow)
Faculty: K. Zimm
No required text.
Not open to students who have completed RAQA 487.

WEEKEND COURSE
5477. Good Manufacturing Practices (992) crn: 46249 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course is offered both on-campus at Ft Washington or online. If you prefer the On-Campus Section, click here.
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.
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.

5494. Quality Audit (990) crn: 25897 (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 proctored exam.
Prerequisite: a good practices course: GLPs (5476), GMPs (5477), Advanced GMPs (5479), or GCPs (5536).
7:00 pm - 10:00 pm Wednesdays: Sept 13, 20, 27, Oct 4, 11, 18, 25, Nov 1, 8, 15, 29, Dec 6, 13. Meets 12 times plus final exam. No class Nov 22. Make-up, if needed, Dec 20.
Proctored exams: Oct 25 and Dec 13 (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.’

5494. Quality Audit (991) crn: 51968 (ONLINE) Expectations of Online Students Registration Form for Online Courses CLOSED. WAIT LIST ONLY.
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.
Prerequisite: a good practices course: GLPs (5476), GMPs (5477), Advanced GMPs (5479), or GCPs (5536).
6:00 pm – 9:00 pm Thursdays: Sept 14, 21, 28, Oct 5 (recording), 12, 19, 26, Nov 2, 9, 16, 30, Dec 7. Meets 12 times plus final exam. No class Nov 23 (Thanksgiving). Make-ups, if needed, Dec 14 and 21.
Proctored exam: Oct 26 (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: 46250 (ONLINE) Expectations of Online Students Registration Form for Online Courses CLOSED. WAIT LIST ONLY.
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.
Prerequisite: Drug Development (5459) or Food and Drug Law (5592).
6:00 pm - 9:00 pm Tuesdays: Sept 12, 19, 26, Oct 3, 17, 24, 31, Nov 7, 14, 21, 28. Meets 12 times plus final exam. No class Oct 10. Make-ups, if needed, Dec 12 and 19.
Proctored exam: Oct 24 (RPNow)
Faculty: A. Smith
Not open to students who completed RAQA 495.

Proctored exam: Oct 28 (RPNow
Faculty: P. Smith
Not open to students who completed RAQA 495.

5496. Regulation of Medical Devices: Compliance (990) crn: 51969 (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 proctored exam.
6:00 pm - 9:00 pm Tuesdays: Sept 12, 19, 26, Oct 3, 10, 17, 24, 31, Nov 7, 14, 28, Dec 5. Meets 12 times plus final exam. No class Nov 21. Make-ups, if needed, Dec 12 and 19.
Proctored exam: Oct 24 (RPNow)
Faculty: M. Arentz
No required text.
Not open to students who have completed RAQA 496.

5497. Statistics for Clinical Trials (990) crn: 54366 (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 proctored exam.
No prior knowledge of statistics required. Drug Development (5459) is helpful but not required.
6:00 pm - 9:00 pm Thursdays: Sept 14, 21, 28, Oct 5, 12, 19, 26, Nov 2, 9, 16, 30, Dec 7. Meets 12 times plus final exam. No class Nov 23 (Thanksgiving). Make-ups, if needed, Dec 14 and 21.
Proctored exam: Oct 26 (RPNow)
Faculty: K. Weiss
No required text.
Not open to students who have completed RAQA 497.

DAYTIME ONLINE COURSE with recordings
5498. Computerized Systems Validation (990) crn: 54367 (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 proctored exam.
Noon - 1:00 pm Tuesdays and Thursdays (Eastern time), plus one hour recording each week, which students must watch before the next scheduled class:
Sept 12, 14 - watch recording before Sept 19
Sept 19, 21 - watch recording before Sept 26
Sept 26, 28 - watch recording before Oct 3
Oct 3, 5 - watch recording before Oct 10
Oct 10, 12 – watch recording before Oct 17
Oct 17, 19 - watch recording before Oct 24
Oct 24, 26 - watch recording before Oct 31
Oct 31, Nov 2 - watch recording before Nov 7
Nov 7, 9 - watch recording before Nov 14
Nov 14, 16 - watch recording before Nov 21
Nov 21 and 28 - watch recording before Dec 5, no class Nov 23, Thanksgiving
Dec 5 and 7 (last live class)
Make-ups, if needed, Dec 12 and 14.
Proctored exam: Oct 19 (RPNow)
Faculty: T. Preziosi
No required text.
Not open to students who completed RAQA 498.

5501. Development of Sterile Products (990) crn: 54368 (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 proctored exam.
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 Mondays: Sept 11, 18, 25 (Yom Kippur), Oct 2, 9 (Columbus Day), 16, 23, 30, Nov 6, 13, 20, 27, Dec 4. Meets 12 times plus final exam. Make-ups, if needed, Dec 11 and 18.
Proctored exam: Dec 4 (RPNow)
Faculty: D. Casaburi
No required text:
Not open to students who have completed RAQA 501.

OPEN ONLY TO STUDENTS PURSUING THE MS in GCPR or the Global Pharmacovigilance Certificate
5508. Good Pharmacovigilance Operations (990) crn: 51972 (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 proctored exam.
7:00 pm – 10:00 pm Thursdays: Sept 14, 21, 28, Oct 5, 12, 19, 26, Nov 2, 9, 16, 30, Dec 7, 14. Meets 12 times plus final exam. No class Nov 23 (Thanksgiving). Make-up, if needed, Dec 21.
Proctored final exam: Dec 14 (RPNow)
Faculty: J. Robinson
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.

5512. Microbiological Concepts in Pharmaceutical Manufacturing (990) crn: 51973 (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 proctored exam.
Prerequisites: 1) Strong science background, 2) Food and Drug Law (5592), 3) Any GxPs (5476, 5477, 5479, or 5536)
6:30 pm - 8:00 pm Tuesdays and Thursdays: Sept 19, 21, 26, 28, Oct 3, 5, 10, 12, 17, 19, 24, 26, 31 Nov 2, 7, 9, 14, 16, 21, 28, 30, Dec 5, 7, 12. Meets 24 times plus final exam. No class Nov 23 (Thanksgiving). Class meets 24 times plus final exam. Make-ups, if needed, Dec 14 and 19.
Proctored exam: Oct 31 (RPNow)
Faculty: R. Saha
No required text: all readings will be available through Internet sources.
Not open to students who have completed RAQA 512.

5513. Active Pharmaceutical Ingredients (990) crn: 49389 (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 proctored exam.
Prerequisite: Drug Development (5459)
6:00 pm – 9:00 pm Thursdays: Sept 14, 21, 28, Oct 5, 12, 19, 26, Nov 2, 9, 16, 30, Dec 7. Meets 12 times plus final exam. No class Nov 23 (Thanksgiving). Make-ups, if needed, Dec 14 and 21.
Proctored exam: Oct 23 (RPNow)
Faculty: K. Zimm
No required text.

5514. Regulatory eSubmissions (990) crn: 54370 (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 proctored exam.
Prerequisite: Drug Development (5459).
6:00 pm - 9:00 pm Wednesdays: Sept 13, 20, 27, Oct 4, 11, 18, 25, Nov 1, 8, 15, 29, Dec 6. Meets 12 times plus final exam. No class Nov 22. Make-ups, if needed, Dec 13 and 20.
Proctored exam: Oct 25 (RPNow)
Faculty: R. Arbaugh
No required text.

5515. Biologics/Biosimilars: A Regulatory Overview (990) crn: 28574 (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 proctored exam.
Prerequisite: Drug Development (5459) and a science background.
6:00 pm - 9:00 pm Wednesdays: Sept 13, 20, 27, Oct 4, 11, 18, 25, Nov 1, 8, 15, 29, Dec 6. Meets 12 times plus final exam. No class Nov 22. Make-ups, if needed, Dec 13 and 20.
Proctored exam: Oct 25 (RPNow)
Faculty: F. Diana|
No required text.

5516. There is an on-campus section of Cleaning Validation. See the On-campus schedule to register.

WEEKEND COURSE
5516. Cleaning Validation (990) crn: 46251 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course is offered both online and on-campus at Fort Washington If you prefer the On-Campus section, click here.
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 (via Zoom)
Faculty: A. Walsh
Required text: Cleaning Validation: Science, Risk and Statistics-based Approaches, A. Walsh. Order from: www.centerforpharmaceuticalcleaninginnovation.org/textbook-page.html

5533. Requirements for Product Labeling and Advertising (990) crn: 51974 (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 proctored exam.
Prerequisite: Food and Drug Law (5592) or permission of instructor.
6:00 pm - 9:00 pm Tuesdays: Sept 12, 19, 26, Oct 3, 10, 17, 24, 31, Nov 7, 14, 21, 28, Dec 5. Meets 12 times plus final exam. Make-ups, if needed, Dec 12 and 19.
Proctored exam: Dec 5 (RPNow)
Faculty: D. Cooke and S. Desai
No required text.
Not open to students who have completed RAQA 533.

5536. Good Clinical Practices (990) crn: 9358 (ONLINE) Expectations of Online Students Registration Form for Online Courses CLOSED. WAIT LIST ONLY.
This course will use PSI RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to PSI via credit card at the start of the proctored exam.
6:00 pm – 9:00 pm Tuesdays: Sept 12, 19, 26, Oct 3, 10, 17, 24, 31, Nov 7, 14, 21, 28. Meets 12 times plus final exam. Make-ups, if needed, Dec 5 and 12.
Proctored exam: Oct 24 (RPNow)
Faculty: D. Weiss
No required text.
Not open to students who have completed RAQA 536.

5537. Clinical Trial Management (990) crn: 49401 (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 proctored 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 Wednesdays: Sept 13, 20, 27, Oct 4, 11, 18, 25, Nov 1, 8, 15, 29, Dec 6. Meets 12 times plus final exam. No class Nov 22. Make-ups, if needed, Dec 13 and 20.
Proctored exam: Oct 25 (RPNow)
Faculty: J. Scavone
No required text.
Not open to students who have completed RAQA 537.

5546. Global Excipient Regulation (990) crn: 46254 (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 proctored exam.
6:00 pm - 9:00 pm Wednesdays: Sept 13, 20, 27 (recording), Oct 4, 11, 18, Nov 1, 8, 15, 29, Dec 6, 13. Meets 12 times plus final exam. No class Oct 25 and Nov 22. Make-ups, if needed, Dec 20.
Proctored exam: Oct 18 (RPNow)
Faculty: D. Schoneker
No required text.
Not open to students who have completed RAQA 546.

5548. Risk Management for Pharmaceutical and Medical Devices (990) crn: 42737 (ONLINE) Expectations of Online Students Registration Form for Online Courses CLOSED. WAIT LIST ONLY.
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 Mondays: Sept 11, 18, 25 (Yom Kippur), Oct 2, 9 (Columbus Day), 16, 23, 30, Nov 6, 13, 20, 27. Meets 12 times plus final exam. Make-ups, if needed, Dec 4 and 11.
Proctored exam: Oct 23 (RPNow)
Faculty: T. Genova
No required text.

STARTS in OCTOBER
5572. Vaccines: RA and QA Issues (990) crn: 39783 (ONLINE) Expectations of Online Students Registration Form for Online Courses CLOSED. WAIT LIST ONLY.
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.
Prerequisite: Drug Development (5459).
6:00 pm - 9:30 pm Tuesdays: Oct 3, 10, 17, 24, 31, Nov 7, 14, 21, 28, Dec 6. Meets 10 times plus final exam. Make-ups, if needed, Dec 13 and 20.
Proctored exam: Oct 31 (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.

5574. Pharmaceutical Quality Management Systems (990) crn: 46256 (ONLINE) Expectations of Online Students Registration Form for Online Courses CLOSED. WAIT LIST ONLY.
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.
Prerequisite: Drug Development (5459).
6:00 pm - 9:30 pm Mondays: Sept 11, 18, 25 (Yom Kippur), Oct 2, 9 (Columbus Day), 16, 23, 30, Nov 6, 20. Meets 10 times plus final exam. No class Nov 13. Make-ups, if needed, Nov 27 and Dec 4.
Proctored exam: Oct 16 (RPNow)
Faculty: M. Labruto
No required text.
Required text: Quality Systems and Control for Pharmaceuticals, Sarkar, Dipak, K., 2008 (ISBN: 978-0470056929).

5577. Global CMCs: Biopharmaceuticals and Other Biologics (990) crn: 28578 (ONLINE) Expectations of Online Students Registration Form for Online Courses CLOSED. WAIT LIST ONLY.
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 Mondays: Sept 11, 18, 25 (Yom Kippur), Oct 2, 9 (Columbus Day), 16, 23, 30, Nov 6, 13, 20, 27. Meets 12 times plus final exam. Make-ups, if needed, Dec 4 and 11.
Proctored exam: Oct 16 (RPNow)
Faculty: J. Quinn
Required text: The Challenge of CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics, John Geigert, 3rd edition, 2019, Science & Media, NY, ISBN-13: 978-3030137533).

5591. Global Regulatory Affairs (990) crn: 23442 (ONLINE) Expectations of Online Students Registration Form for Online Courses CLOSED. WAIT LIST ONLY.
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.
Prerequisite: Drug Development (5459) or Food and Drug Law (5592).
6:00 pm - 9:00 pm Thursdays: Sept 14, 21, 28, Oct 5, 12, 19, 26, Nov 2, 9, 16, 30, Dec 7. Meets 12 times plus final exam. No class Nov 23 (Thanksgiving). Make-ups, if needed, Dec 14 and 21.
Proctored exam: Oct 19 (RPNow)
Faculty: D. Laarkins
No required text.
Not open to students who have completed RAQA 591.

5592. Food and Drug Law (990) crn: 7202 (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 proctored exam.
6:00 pm - 9:00 pm Wednesdays: Sept 13, 20, 27, Oct 4, 11, 18, 25, Nov 1, 8, 15,22, 29. Meets 12 times plus final exam. Make-ups, if needed, Dec 6 and 13.
Proctored exam: Oct 11 (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: 23754 (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 proctored exam.
6:00 pm - 9:00 pm Tuesdays: Sept 12, 19, 26, Oct 3, 10, 17, 24, 31, Nov 7, 14, 21, 28. Meets 12 times plus final exam. Make-ups, if needed, Dec 5 and 12.
Proctored exam: Oct 10 (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.

Special note: there is an on-campus section of Food and Drug Law at Fort Washington on Tuesday afternoons. If you prefer an on-campus section, click here.

5595. Food Law (990) crn: 54379 (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 proctored exam.
6:30 pm - 9:30 pm Mondays: Sept 11, 18, 25 (Yom Kippur), Oct 2, 9 (Columbus Day), 16, 30, Nov 6, 13, 20, 27, Dec 4, 11. Meets 12 times plus final exam. No class Oct 23. Make-up, if needed, Dec 18.
Proctored exam: Dec 11 (RPNow)
Faculty: M. Noonan
No required text.

WEEKEND COURSE
5612. Bioethics for Pharmaceutical Professionals (990) crn: 42739 (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 proctored exam.
10:00 am - 1:00 pm Saturdays: Sept 16, 23, 30, Oct 7 (Columbus Day weekend), 14, 21, 28, Nov 4, 11 (Veterans Day), 18, Dec 2, 9. Meets 12 times plus final exam. No class Nov 25. Make-up, if needed, Dec 16.
Proctored exam: Oct 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.

PHARMACEUTICAL SCIENCE COURSE – strong science background required

8002. There is an on-campus section of Pharmaceutical Analysis. If you prefer to take that section, click here.

8002. Pharmaceutical Analysis (990) crn: 46377 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course is offered both online and on-campus at Fort Washington. If you prefer the On-Campus section, click here.
Prerequisite: strong science backgrounds. This consists of 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 18.
Proctored exams: Oct 23 and Dec 11 (via Zoom)
Faculty: D. Canney, A. Fermier, S. Mehrman
No required text.
Not open to students who have completed Pharmaceutics 411.

PHARMACEUTICAL SCIENCE COURSE – strong science background required
8003. Preformulation - Small Molecules (990) crn: 54371 (ONLINE) Expectations of Online Students Registration Form for Online Courses
(Formerly Pharmaceutical Manufacturing I: Preformulation/Formulation)
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.
Prerequisite: Strong science background required. RAQA students must submit their resume for written permission to register.
5:30 pm - 8:30 pm Tuesdays: Sept 12, 19, 26, Oct 3, 10, 17, 24, 31, Nov 7, 14, 21, 28. Meets 12 times plus final exam. Make-ups, if needed, Dec 5 and 12.
Proctored exam: Oct 24 (RPNow)
Faculty: T. Schultz
Required text: Aulton’s Pharmaceutics: The Design and Manufacture of Medicines, Taylor & Aulton, 4th edition, 2013, Churchill Livingstone, (ISBN: 9780702042904 or 9780702053931).
Not open to students who have completed Pharmaceutics 406.

School of Pharmacy

School of Pharmacy