Summer 2025 Schedule for the RAQA Graduate Program (Updated Apr 21, 2025)
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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
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) 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 have administrative access for your laptop or computer, which means you can install software. (Office computers may have built-in firewalls that do 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, $100 for the third, and $150 per exam thereafter. For more on this policy, click here.
Courses are listed numerically, so scroll down to learn their dates, times, and instructors:
5650. Pharmaceutical Regulatory Leadership (On-Campus Course at RAQA's Fort Washington Location with online sessions. If you are a remote student and wish to take this course, contact QARAREG@temple.edu)
FULL SCHEDULE OF SUMMER 2025 COURSES
NEW COURSE – 1.5 Credits
5000. FDA Inspection Readiness (111) crn: 13923 (ONLINE) (1.5 credits) Proctorio online proctoring Expectations of Online Students Registration Form for Online Courses
6:00 pm - 9:00 pm Tuesdays: May 20, 27, June 3, 10, 17, 24, July 1. Meets 6 times plus final exam. Make-ups, if needed, July 8 and 15.
Proctored exam: July 1 (Proctorio)
Faculty: E. Pittman
No required text.
Description: Addresses the regulations authorizing - and the policies covering - FDA inspections. Topics are approached from the initiation of the inspection (including hosting regulators on-site) to how to address and respond to observations or discussion points. Topics include how inspections, investigations, and sample collections are authorized under the FD&C Act; FDA inspection policies and compliance programs; responding to FDA 483s; internal follow-up to inspections; and other pertinent matters.
5000. Critical Case Study Analysis of Mainstream Pharmaceutical Literature (112) (ONLINE) crn: 14468 (1.5 credits) Expectations of Online Students Registration Form for Online Courses
Special note: this is a 1.5 credit course.
6:00 pm - 9:00 pm Thursdays: June 5, 12, 19, 26, July 10, 17. Meets 6 times plus final exam. No class July 3. Make-ups, if needed, July 24 and 31.
Faculty: K Zimm
Required text: Kill Shot: A Shadow Industry, A Deadly Disease, Jason Dearen.
5459. Drug Development (990) crn: 2539 (ONLINE) Proctorio online proctoring.Expectations of Online Students Registration Form for Online Courses
6:00 pm - 9:00 pm Wednesdays: May 21, 28, June 4, 11, 18, 25, July 2, 9, 16, 23, 30, Aug 6. Meets 12 times plus final exam. Make-ups, if needed, Aug 13 and 20.
Proctored exam: June 25 (Proctorio)
Faculty: C. Ciliberto
Suggested text: Drugs, From Discovery to Approval, 3rd edition, Rick Ng, ISBN-13:978-1118907276 or ISBN-10: 1118907272.
Not open to students who have completed RAQA 459.
WEEKEND COURSE
5459. Drug Development (991) crn: 6040 (ONLINE) Proctorio online proctoring Expectations of Online Students Registration Form for Online Courses
9:00 am - 12:00 pm Sundays: May 18, June 1, 8, 15, 22, 29, July 13, 20 (recording), 27, Aug 3, 10, 17. Meets 12 times plus final exam. No classes on May 25 and July 6. Make-up, if needed, Aug 24.
Proctored exam: July 13 (Proctorio)
Faculty: M. Rubio
Suggested text: Drugs, From Discovery to Approval, 3rd edition, Rick Ng, ISBN-13:978-1118907276 or ISBN-10: 1118907272.
Not open to students who have completed RAQA 459.
5472. Pharmaceutical Marketing (990) crn: 13919 (ONLINE) Proctorio online proctoring Expectations of Online Students Registration Form for Online Courses
6:00 pm - 9:00 pm Wednesdays: May 21, 28, June 4, 11, 18, 25, July 2, 9, 16, 23, 30, Aug 6. Meets 12 times plus final exam. Make-ups, if needed, Aug 13 and 20.
Proctored exam: July 2 (Proctorio)
Faculty: D. Hisey
Required text: Understanding Pharma The Professional's Guide To How Pharmaceutical And Biotech Companies Really Work, 3rd Edition, John J. Campbell
Not open to students who have completed RAQA 482.
5477. Good Manufacturing Practices (990) crn: 4136 (ONLINE) Proctorio online proctoring Expectations of Online Students Registration Form for Online Courses
6:00 pm - 9:30 pm Mondays: May 19, June 2, 9, 16, 23, 30, July 7, 14, 28, Aug 4, 18. Meets 10 times plus final exam. No class May 26 (Memorial Day), July 21, and Aug 11. Make-up, if needed, Aug 25.
Proctored exam: Aug 18 (Proctorio)
Faculty: M. Noonan
No required text.
Not open to students who have completed RAQA 487.
5478. High Purity Water Systems (990) crn: 12414 (ONLINE) Proctorio online proctoring Expectations of Online Students Registration Form for Online Courses
Prerequisite: college-level chemistry course.
6:00 pm – 9:00 pm Tuesdays: May 20, 27, June 3, 10, 17, 24, July 1, 8, 15, 22, 29, Aug 5, 12. Meets 12 times plus final exam. Make-ups, if needed, Aug 19 and 26.
Proctored exam: Aug 12 (Proctorio)
Faculty: W. Collentro
Reference text (available on Charles Library website for registered students): Pharmaceutical Water - System Design, Operation, and Validation, Collentro, 2nd edition, Informa Healthcare, 2011.
Not only to students who have taken RAQA 488.
5479. Advanced Good Manufacturing Practices – Defining “c” (990) crn: 7676 (ONLINE) Proctorio Online Proctoring Expectations of Online Students Registration Form for Online Courses
Prerequisite: successful completion of Good Manufacturing Practices (5477) or permission of the instructor.
6:00 pm - 9:00 pm Wednesdays: May 21, 28, June 4, 11, 18, 25, July 2, 9, 16, 23, 30, Aug 6. Meets 12 times plus final exam. Make-ups, if needed, Aug 13 and 20.
Proctored exam: June 25 (Proctorio)
Faculty: K. Zimm
No required text.
5494. Quality Audit (990) crn: 4137 (ONLINE) Proctorio online proctoring Expectations of Online Students Registration Form for Online Courses
Prerequisite: A Good Practices course (5476 or 5477 or 5479 or 5536).
6:30 pm - 9:45 pm Wednesdays: May 21, 28, June 4, 11, 18, 25, July 2, 9, 16, 23, 30, Aug 6, 13. Meets 12 times plus final exam. Make-ups, if needed, Aug 20 and 27.
Proctored exam: Aug 13 (Proctorio)
Faculty: S. Van Valkenburg
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.
WEEKEND COURSE
5495. IND/NDA Submissions (990) crn: 13915 (ONLINE) Proctorio online proctoring Expectations of Online Students Registration Form for Online Courses
Prerequisite: Drug Development (5459) or Food and Drug Law (5592).
8:30 am – 2:00 pm Saturdays: May 17, 31, June 14, 28, July 12, 26, Aug 9. Meets 7 times plus final exam. Make-up, if needed, Aug 16.
Proctored exam: June 28 (Proctorio)
Faculty: P. Smith
Required text: New Drug Development: A Regulatory Overview, Mathieu, 8th revised edition.
Not open to students who have completed RAQA 495.
5496. Regulation of Medical Devices: Compliance (990) crn: 14469 (ONLINE) Proctorio online proctoring Expectations of Online Students Registration Form for Online Courses
6:00 pm - 9:00 pm Thursdays: May 22, 29, June 5, 12, 19, 26, July 10, 17, 24, 31, Aug 7, 14. Meets 12 times plus final exam. No class July 3. Make-ups, if needed, Aug 21 and 28.
Proctored exam: July 10 (Proctorio)
Faculty: M. Arentz
No required text.
Not open to students who have completed RAQA 496.
5514. Regulatory eSubmissions (990) crn: 13918 (ONLINE) Proctorio online proctoring. Expectations of Online Students Registration Form for Online Courses
Strongly Suggested Prerequisite: Drug Development (5459) OR IND/NDA Submissions (5495) OR forward your resume indicating familiarity with drug development or IND/NDA processes.
6:00 pm - 9:00 pm Tuesdays: May 20, 27, June 3, 10, 17, 24, July 8, 15, 22, 29, Aug 5, 12. Meets 12 times plus final exam. No class July 1. Make-ups, if needed, Aug 19 and 26.
Proctored exam: June 24 (Proctorio)
Faculty: R Arbaugh
No required text.
5515. Biologics/Biosimilars: A Regulatory Overview (990) crn: 14470 (ONLINE) Proctorio online proctoring Expectations of Online Students Registration Form for Online Courses
Prerequisites: Drug Development (5459). Science background required.
6:00 pm - 9:00 pm Wednesdays: May 21, 28, June 4, 11, 18, 25, July 2, 9, 16, 23, 30, Aug 6. Meets 12 times plus final exam. Make-ups, if needed, Aug 13 and 20.
Proctored exam: July 9 (Proctorio)
Faculty: F. Diana
No required text.
5536. Good Clinical Practices (990) crn: 3423 (ONLINE) Proctorio online proctoring Expectations of Online Students Registration Form for Online Courses
6:00 pm - 9:00 pm Mondays: May 19, June 2, 9, 16, 23, 30, July 7, 14, 21, 28, Aug 4, 11. Meets 12 times plus final exam. No class May 26 (Memorial Day). Make-ups, if needed, Aug 18 and 25.
Proctored exam: July 7 (Proctorio)
Faculty: J. Hayes
Optional texts (Students will be required to choose one of the following after the first class):
1) Polio: An American Story; D.M. Oshinsky.
2) Do You Believe in Magic? (The Sense and Nonsense of Alternative Medicine (Vitamins, Supplements, and All Things Natural: A Look Behind the Curtain), P. Offit;
3) The Chimp & the River: How AIDS Emerged from an African Forest, D. Quamman;
4) The Speckled Monster: a Historical Tale of Battling Smallpox, J.L Carrell
Not open to students who have completed RAQA 536.
5537. Clinical Trial Management (990) crn: 5872 (ONLINE) Proctorio online proctoring Expectations of Online Students Registration Form for Online Courses
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 Tuesdays: May 20, 27, June 3, 10, 17, 24, July 1, 8, 15, 22, 29, Aug 5. Meets 12 times plus final exam. Make-ups, if needed, Aug 12 and 19.
Proctored exam: July 1 (Proctorio)
Faculty: J. Scavone
No required text.
Not open to students who have completed RAQA 537.
5538. Clinical Drug Safety and Pharmacovigilance (990) crn: 13333 (ONLINE) Proctorio online proctoring Expectations of Online Students Registration Form for Online Courses
Suggested prerequisite: Good Clinical Practices (5536)
7:00 pm - 10:15 pm Thursdays: May 29, June 5, 12, 19, 26, July 10, 17, 24, 31, Aug 7, 14, 21. Meets 11 times plus final exam. No class July 3. Make-up, if needed, Aug 28.
Proctored exam: Aug 21 (Proctorio).
Faculty: J. Robinson
Recommended text: Cobert’s Manual of Drug Safety and Pharmacovigilance, 4th edition only, Feb 2025, Cobert, Gregory, Thomas, Baldridge: https://www.worldscientific.com/worldscibooks/10.1142/13970#t=aboutBook
5543. Good Distribution Practices (990) crn: 14471 (ONLINE) Proctorio online proctoring Expectations of Online Students Registration Form for Online Courses
Prerequisite: Good Manufacturing Practices (5477)
6:00 pm - 9:00 pm Wednesdays: May 21, 28, June 4, 11, 18, 25, July 2, 9, 16, 23, 30, Aug 6. Meets 12 times plus final exam. Make-ups, if needed, Aug 13 and 20.
Proctored exam: June 25 (Proctorio)
Faculty: J. Hayes
Students will select one of the following and present a summary in class:
1) Making a Killing: The Deadly Implications of the Counterfeit Drug Trade, R. Bate. OR
2) China Rx: Exposing the Risks of America’s Dependence on China for Medicine; Gibson; ISBN-10: 1633886417 OR
3) Protecting America’s Health: FDA, Business, & One Hundred Years of Regulation; Hilts; ISBN-10: 0807855820.
5545. Post-Approval Changes (PAC) (990) crn: 14472 (ONLINE) Proctorio online proctoring Expectations of Online Students Registration Form for Online Courses
6:00 pm - 9:00 pm Mondays: May 19, June 2, 9, 16, 23, 30, July 7, 14, 21, 28, Aug 4, 11. Meets 12 times plus final exam. No class May 26 (Memorial Day). Make-ups, if needed, Aug 18 and 25.
Proctored exam: July 7 (Proctorio)
Faculty: K. Zimm
No required text.
5591. Global Regulatory Affairs (990) crn: 1733 (ONLINE) Proctorio online proctoring Expectations of Online Students Registration Form for Online Courses
Prerequisite: Drug Development (5459) or Food and Drug Law (5592).
6:00 pm – 9:00 pm Thursdays: May 22, 29, June 5, 12, 19, 26, July 10, 17, 24, 31, Aug 7, 14. Meets 12 times plus final exam. No class July 3. Make-ups, if needed, Aug 21 and 28.
Proctored exam: June 26 (Proctorio)
Faculty: D. Larkins
No required text.
Not open to students who have completed RAQA 591.
5592. Food and Drug Law (990) crn: 1734 (ONLINE) Proctorio online proctoring Expectations of Online Students Registration Form for Online Courses
6:00 pm - 9:00 pm Tuesdays: May 20, 27, June 3, 10, 17, 24, July 1, 8, 15, 22, 29, Aug 5. Meets 12 times plus final paper. Make-ups, if needed, Aug 12 and 19.
Proctored exam: July 15 (Proctorio)
Faculty: D. Cooke
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 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.
5596. Food Labeling and Regulatory Affairs (990) crn: 13921 (ONLINE) Proctorio online proctoring Expectations of Online Students Registration Form for Online Courses
6:00 pm - 9:30 pm Thursdays: May 22, 29, June 5, 12, 19, 26, July 10, 24, 31, Aug 7, 14. Meets 10 times plus final exam. No class July 3 and July 17. Make-ups, if needed, Aug 21 and 28.
Proctored exam: Aug 14 (Proctorio)
Faculty: M. Noonan
No required text.
5612. Bioethics for Pharmaceutical Professionals (990) crn: 14473 (ONLINE) Proctorio online proctoring Expectations of Online Students Registration Form for Online Courses
10:00 am - 1:30 pm Saturdays: May 17, 31, June 7, 14, 21, 28, July 12, 19, 26, Aug 2, 9. Meets 10 times plus final exam. No class May 24 and July 5. Make-ups, if needed, Aug 16 and 23.
Proctored exam: Aug 9 (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.
NEW COURSE!!
5650. Investigations in Industry (Internal, Quality, and Criminal) (990) crn: 13922 (ONLINE) Proctorio online proctoring Expectations of Online Students Registration Form for Online Courses
Prerequisite: Good Manufacturing Practices (5477) or industry GMP experience (send resume for approval).
6:00 pm - 9:00 pm Mondays: May 19, June 2, 9, 16, 23, 30, July 7, 14, 21, 28, Aug 4, 11. Meets 12 times plus final exam. No class May 26 (Memorial Day). Make-ups, if needed, Aug 18 and 25.
Proctored exam: July 14 (Proctorio)
Faculty: J. Banaszewski
Required text: Handbook of Investigation and Effective CAPA Systems, 3rd edition. J. Rodriguez-Perez
Description:
Description: An in-depth and comprehensive exploration of effective investigation techniques within the pharmaceutical industry, emphasizing root cause analysis (RCA) and the Corrective and Preventive Action (CAPA) process. Designed for professionals seeking to enhance their skills in identifying, analyzing, and resolving quality issues, the course covers the principles and methodologies of conducting thorough investigations to ensure compliance with regulatory standards (e.g., FDA, EMA, ICH). Participants will learn to apply structured RCA tools to uncover underlying causes of deviations, non-conformance, and other quality events.
The course also delves into the CAPA process, guiding learners through the development, implementation, and verification of corrective and preventive actions to mitigate risks and drive continuous improvement. Through case studies, interactive discussions, and practical exercises, participants will gain the knowledge and confidence to lead robust investigations and maintain a culture of quality and compliance in pharmaceutical operations.
AFTERNOON COURSE at Fort Washington – SOME CLASSES MEET ONLINE. Contact QARAREG@temple.edu if you wish to enroll but can’t attend on-campus.
5650. Pharmaceutical Regulatory Leadership (101) crn: 13914 Expectations of Graduate Students
Suggested prerequisite: Drug Development (5459) OR Food and Drug Law (5592).
2:00 pm – 5:30 pm Wednesdays: May 21, 28, June 4, 11, 18, 25, July 2, 9, 16, 23. Meets 10 times plus final exam. Make-ups, if needed, July 30 and Aug 6.
In-class/online proctored exam: June 18
Faculty: P. Sax
Suggested texts: 1) The Practice of Management, Drucker; 2) The Definitive Drucker, E.H Edersheim; 3) Who Moved My Cheese, S Johnson.
Description: Leading in the pharmaceutical industry requires more than regulatory knowledge: it requires key skills to get the job done with various constituents, including coworkers, employees, and management. This course provides insights, rules, tools and requirements needed to lead in the highly regulated pharmaceutical industry. Students will study organizational principles and practices within the framework of the Code of Federal Regulations (specifically 21 CFR 210, 211, 312, 600 and 820). While these regulations provide what is required, they do not describe how to accomplish it. That task is the job of leadership. Using recommended texts, case studies, class lectures, discussions, and individual research, students will learn how to lead and manage in a regulated industry.
Expectations of Online Students
Registration Form for Online Courses