Spring 2024 Schedule
Advanced Biotherapeutics: Manufacturing and Regulatory Affairs (ABMRA)Offered jointly with the Jefferson Institute of Biotechnology in Springhouse, PA, part of Jefferson University
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Temple U BookstoreA strong science background is required to pursue the MS in Advanced Biotherapeutics: Manufacturing and Regulatory Affairs. This includes a science or engineering undergraduate or graduate degree. Students are expected to complete a minimum of 15 credits in Temple's RAQA graduate program plus a minimum of 15 credits at the Jefferson Institute of Biotechnology in Springhouse, PA. While the majority of courses in this 36-credit MS degree are online, there are a few required courses that must be completed in-person at JIB.
Students may earn the ABMRA degree either from Temple University OR from Thomas Jefferson University (but not both). Students wanting to focus more on RA issues with biopharmaceuticals should pursue the TU degree; students wishing to focus more on hands-on manufacturing issues of biopharmaceuticals should pursue the Jefferson degree.
Required Courses from Temple and Jefferson:
Drug Development (5459) (Temple RAQA)
Biologics/Biosimilars: A Regulatory Overview (5515) (Temple RAQA)
Global CMCs - Biologics (5577) (Temple RAQA)
Vaccines: RA and QA Aspects (5572) (Temple RAQA)
One approved RAQA elective for the ABMRA degreeBioprocess Engineering for Scientists (ENGR 609) (3 credits)
Intro to Biopharmaceutical and Biologics Production (ENGR 621) (3 credits)
Principles of Biopharmaceutical Process Engineering (ENGR 611) (3 credits)
Biopharmaceutical Process Operations (ENGR 604) (3 credits)
One approved JIB elective for the ABMRA degreeAfter completing required courses, students pursue 6 credits from either JIB or RAQA, depending on whether they earn the degree from
Thomas Jefferson University or Temple University.You are expected to take proctored exams on the dates listed in the Schedule. There is a first time fee of $25 charged to any student who cannot take the exam on the designated date and requests a makeup test; in subsequent semesters, the fee increases to $35 per exam and then $50 per exam. For more information on proctoring and these fees, click here.
Spring 2024 ABMRA Schedule
Spring 2024 online courses use Zoom as the teaching platform. Temple provides Zoom for free to all registered Temple students.
Some ABMRA courses are also offered on-campus at RAQA's Fort Washington location. International students with F-1 visas are required to take on-campus courses or to pursue online courses in the Fort Washington Computer Lab and must take JIB courses at the Springhouse, PA, site of that program.
Required hardware
Our online courses are interactive, so you must have a webcam and microphone. Many laptops already have built-in webcams and speakers. If you use a device that does not, you will be required to purchase them.If you're a new student, watch our online course tutorial. A password is given at the end which must be included on your registration form.
After watching the tutorial, schedule a short Zoom 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 RAQA class meeting.
RPNow is an online proctoring service that enables you to take exams at almost any location. RPNow charges $15.00 per exam, which you must pay with a credit card at the start of each exam. (You must also pay that fee if you take in RPNow exam in a University computer lab.) If a course uses RPNow, all students in the class must use that service.
You must have a laptop or computer for RPNow exams. (Chrome notebooks, iPad, 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 now allow software downloads.) Please check this before registering.
REQUIRED COURSES for the MS in Advanced Biotherapeutics: Manufacturing and RA (ABMRA)
Students pursuing the ABMRA MS must take required courses before registering for electives. Most required courses are only offered once a year.
REQUIRED RAQA COURSES
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 proctored 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 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 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 proctored 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.
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 proctored 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, 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.ELECTIVE COURSES – ABMRA
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.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 proctored 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: Required text: Statistical Quality Control, 7th or latest edition, D.C. Montgomery.
Not open to students who have completed RAQA 451.5468. 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 proctored 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 proctored 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.
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 proctored 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 8484.5493. 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 proctored 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 493.5514. 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 proctored 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.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 proctored 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.SIX WEEK SCHEDULE TWICE A WEEK
5571. Post Marketing Safety Surveillance (990) crn: 42724 (ONLINE) Students may take 5538 OR 5571, but not both. 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 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 571.5574. 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 proctored 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 proctored 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.
To register for the Online courses use:
Expectations of Online Students Registration Form for Online Courses
Email your registration form to: QARAREG@temple.edu
OR, PRINT AND FAX YOUR REGISTRATION TO: 267.468.8565
OR, MAIL YOUR REGISTRATION TO:
Temple University
Regulatory Affairs and Quality Assurance Graduate Program
425 Commerce Drive, Suite 175
Ft. Washington, PA 19034
Is this your first registration in the non-thesis MS program? If so, you must forward a RESIDENCY FORM. Call RAQA at 267.468.8560 for instructions.
Will this be your fourth course in the MS program? If so, you must fax a Non-Matriculated Graduate Student Waiver