Fall 2024 Schedule
Advanced Biotherapeutics: Manufacturing and Regulatory Affairs (ABMRA) (Updated Aug 28, 2024)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. To earn this degree, students 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. Most courses are in this 36-credit MS degree are online. Students are strongly encouraged to enjoy the outstanding state-of-the-art equipment available at the Jefferson Institute of Biotechnology in Springhouse, PA, whenever possible.
Students may earn the ABMRA degree either from Temple University OR from Thomas Jefferson University (but not both). Students wanting to focus on RA issues with biopharmaceuticals should pursue the TU degree; students wishing to focus 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 Jefferson or Temple University.
Fall 2024 ABMRA Schedule
All RAQA online courses use Zoom. 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 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 are expected to take proctored exams on the dates listed in the Schedule. There is a first time fee of $35 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 $50 per exam and then $100 per exam. For more information on proctoring and these fees, click here.
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 not 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
AFTERNOON On-CAMPUS COURSE at Fort Washington
5459. Drug Development (101) crn: 49409 (ON-CAMPUS COURSE) Expectations of Graduate Students Registration Form for On-Campus Courses
2:00 pm – 5:30 pm Wednesdays: Sept 18, 25, Oct 2 (Rosh Hashanah), 9, 16, 23, 30, Nov 6, 13, 20. Meets 10 times plus final exam. Makeup, if needed, Dec 4 and 11.
In-class, proctored exam: Oct 16.
Faculty: P. Sax
Required texts: 1) Drugs: From Discovery to Approval, Ng, 3rd edition, 2015 (ISBN-13:978-1118907276 or ISB-101: 1118907272), and 2) The Drug Hunters: the Improbable Quest to Discover New Medicines, Kirsch, 2017.
Not open to students who completed RAQA 459.5459. 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 12, 19, 26, Oct 3 (Rosh Hashanah), 10, 17, 24, 31, Nov 7, 14, 21, Dec 5. No class Nov 28 (Thanksgiving). Meets 12 times plus final exam. Make-ups, if needed, Dec 12 and 19.
Proctored exam: Oct 24 (RPNow)
Faculty: C. Ciliberto
Required text: Drugs: From Discovery to Approval, Ng, 3rd edition, 2015 (ISBN-13:978-1118907276 or ISBN-10: 1118907272).
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 Wednesdays: Sept 11, 18, 25, Oct 2 (Rosh Hashanah), 9, 16, 23, 30, Nov 6, 13, 20, Dec 4. Meets 12 times plus final exam. No class Nov 27. 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-13:978-1118907276 or ISBN-10: 1118907272.
In addition, students will be required to choose one of the following 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.WEEKEND COURSE
5459. Drug Development (992) crn: 28608 (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 Saturdays: Sept 14, 28, Oct 12 (Columbus Day weekend), 26, Nov 9, 23, Dec 7. Meets 7 times plus final exam. Make-up, if needed, Dec 14.
Proctored exam: Oct 26 (RPNow)
Faculty: P. Smith
Required text: Drugs: From Discovery to Approval, third edition, Rick, Ng, ISBN-13:978-1118907276 or ISBN-10: 1118907272.
Not open to students who have completed RAQA 459.5515. 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.
Prerequisites: Drug Development (5459).
6:00 pm - 9:00 pm Wednesdays: Sept 11, 18, 25, Oct 2, 9, 16, 23, 30 (recording), Nov 6, 13, 20, Dec 4. Meets 12 times plus final exam. No class Nov 27. Make-ups, if needed, Dec 11 and 18.
Proctored exam: Oct 23 (RPNow)
Faculty: F. Diana
No required text.5572. Vaccines: RA and QA Issues (990) crn: 39783 (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).
6:00 pm - 9:00 pm Mondays: Sept 9, 16, 23, 30, Oct 7, 14 (Columbus Day), 21, 28, Nov 4, 11 (recording), 18, 25. Meets 12 times plus final exam. Make-ups, if needed, Dec 2 and 9.
Proctored exam: Oct 14 (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,3rd edition, 2019, 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 and Other Biologics (990) crn: 28578 (ONLINE) CLOSED. WAIT LIST ONLY. 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 10, 17, 24, Oct 1, 8, 15, 22, 29, Nov 5, 12, 19, 26. Meets 12 times plus final exam. Make-ups, if needed, Dec 3 and 10.
Proctored exam: Oct 15 (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).RAQA ELECTIVE COURSES: in the ABMRA DEGREE PROGRAM. The following elective courses in ABMRA are offered this fall. Refer to the AMBRA MS link for a complete list of RAQA electives accepted in the degree program.
8005. Pharmaceutical Biotechnology (990) crn: 54372 (ONLINE) Expectations of Online Students Registration Form for Online Courses
6:00 pm – 9:00 pm Thursdays: Sept 12, 19, 26, Oct 3 (Rosh Hashanah), 10, 17 (proctored midterm), 24, 31, Nov 7, 14, 21, Dec 5, 12 (final). No class Nov 28 (Thanksgiving). Meets 12 times plus final exam. Make-up, if needed, Dec 19.
Proctored exams: Oct 17 and Dec 12 (proctored through Zoom)
Faculty: T. Parry
Required text: Pharmaceutical Biotechnology: Fundamentals and Applications, Crommelin, Sindelar & Meibohm, editors, any of the 3rd through 6th 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 475.5492. Production of Sterile Products (990) crn: 56673 (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 12, 19, 26, Oct 3 (Rosh Hashanah), 10, 17, 24, 31, Nov 7, 14, 21, Dec 5, 12. No class Nov 28 (Thanksgiving). Meets 12 times plus final exam. Make-up, if needed, Dec 19.
Proctored exam: Dec 12 (RPNow)
Faculty: D. Casaburi
Required text: Aseptic and Sterile Processing Compliance and Future Trends, Sandle and Tidswell, Parenteral Drug Association, 2017, ISBN 9781942911128. Available in hardcover or digital.
Not open to students who have completed RAQA 492.5474. 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.
6:00 pm - 9:00 pm Thursdays: Sept 12, 19, 26, Oct 3 (Rosh Hashanah), 10, 17, 24, 31, Nov 7, 14, 21, Dec 5. No class Nov 28 (Thanksgiving). Meets 12 times plus final exam. Make-ups, if needed, Dec 12 and 19.
Proctored exam: Oct 17 (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 8484.5538. Clinical Drug Safety and Pharmacovigilance (990) crn: 56672 (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.
ABMRA Students may take 5538 or 5571 as an RAQA elective but not both.
Prerequisite: Good Clinical Practices (5536 or P383) or appropriate experience in industry GCPs (send resume with registration form).
7:00 pm – 10:00 pm Thursdays: Sept 12, 19, 26, Oct 3 (Rosh Hashanah), 10, 17, 24, 31, Nov 7, 14, 21, Dec 5, 12 (final). No class Nov 28 (Thanksgiving). Meets 12 times plus final exam. Make-up, if needed, Dec 19.
Proctored exam: Dec 12 (RPNow)
Faculty: J. Robinson
No required text.5574. Quality Management Systems (990) crn: 46256 (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: Drug Development (5459)
6:00 pm - 9:30 pm Mondays: Sept 16, 23, 30, Oct 7, 14 (Columbus Day), 21, 28 (recording), Nov 4, 11 (Veterans' Day), 18. Meets 10 times plus final exam. Make-ups, if needed, Nov 25 and Dec 2.
Proctored exam: Oct 21 (RPNow).
Faculty: M. LaBruto
No required text.To register for the Online courses use:
Expectations of Online Students
Registration Form for Online Courses
Registration Form for On-Campus 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