Advanced Biotherapeutics: Manufacturing and Regulatory Affairs (ABMRA)
Fall 2023 Schedule
Advanced Biotherapeutics: Manufacturing and Regulatory Affairs (ABMRA)Offered jointly with the Jefferson Institute of Biotechnology in Springhouse, PA, part of Thomas Jefferson University
Order texts on-line:
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.
Fall 2023 ABMRA Schedule
Fall 2023 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 (dbrick@temple.edu) or Mike Doukas (mdoukas@temple.edu) 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 PHARMACEUTICAL REGULATORY SCIENCES
Students pursuing the MS in Pharmaceutical Regulatory Sciences must take required courses before registering for electives. Most required courses are only offered once a year.
REQUIRED RAQA COURSES
DAYTIME ON-CAMPUS COURSE at Fort Washington
5459. Drug Development (Fort Washington) (101) crn: 49409 Registration form for On-Campus Courses
2:00 pm - 5:30 pm Thursdays: Sept 14, 21, 28, Oct 5, 12, 19, 26, Nov 2, 9, 16. Meets 10 times plus final exam. Make-ups, if needed, Nov 30 and Dec 7.
In-class, proctored exam: Oct 12
Faculty: P. Sax
Required texts: 1) Drugs: From Discovery to Approval, Ng, 3rd end, 2015 (ISBN-13:978-1118907276 or ISBN-10: 1118907272) 2) The Drug Hunters: The Improbable Quest to Discover New
Medicines,
Not open to students who have completed RAQA 459 or P381.5459. 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 or P381.5459. 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
Requred 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 SinclairvOR
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 or P381.5459. 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
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 or P381.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 or P381.5515. 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.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 572.5577. Global CMCs: Biopharmaceuticals & 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).ELECTIVE COURSES – ABMRA
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 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: 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. Barnthouse
Required texts:1) Process Validation in Manufacturing of Biopharmaceutics, 3rd ed, Anurag 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 8484.5501. 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 501.5512. 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 512.5514. 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.WEEKEND ON-CAMPUS COURSE at Fort Washington
5516. Cleaning Validation (101) crn: 42747 Registration form for On-Campus Courses
This course is offered both online and on-campus at Fort Washington
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
Faculty: A. Walsh
Required text: Cleaning Validation:Science, Risk and Statistics-based Approaches, A. Walsh. Order from: www.centerforpharmaceuticalcleaninginnovation.org/textbook-page.htmlWEEKEND 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
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. Orderfrom: www.centerforpharmaceuticalcleaninginnovation.org/textbook-page.html
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
Required text: Quality Systems and Control for Pharmaceuticals, Sarkar, Dipak, K., 2008 (ISBN: 978-0470056929).
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 fax a RESIDENCY FORM
Will this be your fourth course in the Pharmaceutics program? If so, you must fax a Non-Matriculated Graduate Student Waiver