QA/RA Spring Schedule (updated March 10, 2014)

Schedule of All Courses (Traditional Classroom and Online)


Starting in the spring semester, students who cannot make the scheduled exam date will be charged a $20.00 fee for a makeup exam. For more on this policy, click here.

----------------------------------------

Classes Already in Session (Closed to any additional registrations now)

5592.  Food and Drug Law I (103)  crn: 9956 
6:00 pm – 9:30 pm Mondays:  STARTS Feb 17 (Presidents’ Day), 24, Mar 3, 10, 17, 24, 31, Apr 7, Apr 14, 21, 28 (proctored, in-class exam).  Meets 10 times plus final exam.  Make-ups, if needed, May 5.  Proctored, in-class exam:  Apr 28.
Faculty:  B. Bollwage
Required text: Food and Drug Law:  Cases and Materials, 3rd ed, Hutt, et al, Foundation Press, (ISBN: 978-1-58778-068-4). Make sure you purchase the 2007 edition (and not earlier editions).  
Not open to students who have taken Pharmaceutics 592.

5650.  CMCs for Biologics (101)  crn:  23319 Click here to learn more about this course.Rm 3
Suggested prerequisites:  Drug Development, IND/NDA Submissions, and Biologics/Biosimilars:  A Regulatory Overview or fax resume for approval.
6:00 pm - 9:30 pm Wednesdays:  Jan 29, Feb 12, 19, 26, Mar 5, 12, 19, 26, Apr 2, 16.  Meets 10 times plus final exam.  Make-up, if needed, Apr 16.  Proctored exam: Mar 5. No class Apr 9.
Faculty:  Ken Surowitz
Required text:  The Challenge of CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics, John Geigert, 2nd ed, 2013, Science & Media, NY.

5408.  Pharmacoeconomics (101)  crn: 20651
6:00 pm – 9:30 pm Tuesdays: Jan 28, Feb 4, 11, 18, 25, Mar 4, 11, 18, 25, Apr 1, 8(in-class, proctored exam).  Meets 10 times plus final exam.  Make-up, if needed, Apr 15.  Proctored, in-class exam:  April 8.
Faculty:  A. Wertheimer
Required text: Pharmacoeconomics Principles and Practices, L Pradelli and A Wertheimer, SEEd Publications, Torino, Italy, (ISBN:  978-88-9741-937-2).
Not open to students who have taken Pharmaceutics 480.

5459. Drug Development (101)  crn: 7314
6:00 pm – 9:30 pm Mondays:  Jan 27,  Feb 10, 17 (Presidents' Day), 24, Mar 3, 10, 17, 24, 31, Apr 7.  Meets 10 times plus final exam.  Make-ups, if needed, Apr 21 or 28.  Proctored in-class exam:  Mar 24. (Note: Feb 3 class cancelled due to snow.)
Faculty:  B. Berger
Required text:  New Drug Development: A Regulatory Overview, Mathieu, 8th ed, (ISBN: 1-882615-85-9).
Not open to students who have taken Pharmaceutics 459.
Videoconferenced to Temple U Center City.

5459.  Drug Development (102)  crn: 7315
8:30 am – 5:00 pm Saturdays (1 hour lunch):  Jan 25, Feb 8, 22, Mar 8, 22.  Meets 5 times plus final exam.  Make-up, if needed, Apr 5 or 26.  Proctored, in-class exam:  Feb 22
Faculty:  C. Ciliberto
Required text:  New Drug Development: A Regulatory Overview, Mathieu, 8th ed, (ISBN: 1-882615-85-9).
Not open to students who have taken Pharmaceutics 459.

Temple University Center City
5459. Drug Development (401) crn:  23281
This course is videoconferenced from Temple U Ft Washington to TUCC.
6:00 pm – 9:30 pm Mondays:  Jan 27,  Feb 10, 17 (Presidents' Day), 24, Mar 3, 10, 17, 24, 31, Apr 7.  Meets 10 times plus final exam.  Make-ups, if needed, Apr 21 or 28.  Proctored in-class exam:  Mar 24.
Faculty:  B. Berger
Required text:  New Drug Development: A Regulatory Overview, Mathieu, 8th ed, (ISBN: 1-882615-85-9).
Not open to students who have taken Pharmaceutics 459.

Tarrytown, NY
5459.  Drug Development (318) 
This course meets in Tarrytown, NY, by the Tappan Zee Bridge.
8:30 am - 5:00 pm (1 hour lunch) Sundays:  Feb 2, 16, Mar 2, 16, 30.  Meets 5 times plus final exam.  Make-up, if needed, Apr 13.  Proctored, in-class exams:  Mar 2 and 30.
Faculty:  L Edwards.
Required text:  Principles and Practice of Pharmaceutical Medicine, Edwards, Fox, and Stonier, 3rd ed, (ISBH:  9781405194723).
Not open to students who have taken Pharmaceutics 459.

5459. Drug Development (990)  crn:  7447  There is an online section of Drug Development on Tuesday nights.  See the Online Course Schedule for Details.  You must use the Registration Form for Online Courses for this class.

5472.  Pharmaceutical Marketing (990) crn:  20665  There is an online section of Pharmaceutical Marketing on Wednesday nights.  See the Online Course Schedule for Details. You must use the Registration Form for Online Courses for this class.

5477. Good Manufacturing Practices (990)  crn:  3439  There is an online section of Good Manufacturing Practices on Thursday nights.  See the Online Course Schedule for Details.  You must use the Registration Form for Online Courses for this class.

5478.  High Purity Water Systems (990)  crn:  23313  There is an online section of High Purity Water Systems on Monday evenings.  See the Online Course Schedule for Details.  You must use the Registration Form for Online Courses for this class. CLOSED. WAIT LIST ONLY.

5493.  Sterilization Processes:  Manufacturing (101)  crn:  23264
Prerequisite:  Strong science background and a basic understanding of pharmaceutical manufacturing processes.
8:30 am - 5:00 pm (1 hour lunch) Saturdays:  Jan 18, Feb 1, 15, Mar 1, 15.  Meets 5 times plus final exam.  Proctored, in-class exam:  Feb 15.  Make-up, if needed, Mar 29 or Apr 12.
Faculty:  D. Casaburi
Required text: Validation of Pharmaceutical Processes, Agalloco and Carleton, CRC Press, 2007, (ISBN-13: 9780849370557).
Not open to students who have taken Pharmaceutics 493.

5494.  Quality Audit (101)  crn:  20674
Prerequisite:  a good practices course (either Pharmaceutics 5476, 5477, 5479 or 5536).
8:30 am – 3:00 pm Sundays (1/2 hour lunch):  Jan 19, Feb 2, 16, Mar 2, 16, 30.  Meets 6 times plus final exam.  Make-ups, if needed, Apr 13.  Proctored, in-class exam:  Mar 2.
Faculty:  T. Preziosi
Required text: The ASQ Auditing Handbook, 3rd  ed, J.P. Russell.  Available from ASQ Quality Audit Division:  www.asq.org  (ISBN:  9780873896665, ASQ Item 1263).
Not open to students who have taken Pharmaceutics 494.

5494. Quality Audit (102) crn: 23315
Prerequisite:  a good practices course (either Pharmaceutics 5476, 5477, 5479 or 5536).
6:00 pm - 9:30 pm Wednesdays:  Jan 29, Feb 5, 19, 26, Mar 5, 12, 19, 26, Apr 2, 9.  Meets 10 times plus final exam.  Make-up, if needed, Apr 16.  Proctored, in-class exam: Mar 12.
Faculty: F. Stevenson
Required text: The ASQ Auditing Handbook, 3rd  ed, J.P. Russell.  Available from ASQ Quality Audit Division:  www.asq.org  (ISBN:  9780873896665, ASQ Item 1263).
Not open to students who have taken Pharmaceutics 494.

Tarrytown, NY
5494.  Quality Audit (318) 
This course meets in Tarrytown, NY, by the Tappan Zee Bridge.
Prerequisite:  a good practices course (either Pharmaceutics 5476, 5477, 5479 or 5536).
8:30 am - 5:00 pm (1 hour lunch) Saturdays:  Jan 18, Feb 1, 15, Mar 1, 15.  Meets 5 times plus final exam.  Make-up, if needed, Mar 29.  Proctored, in-class exam:  Mar 15.
Faculty:  S. Van Valkenburg
Required text: The ASQ Auditing Handbook, 3rd  ed, J.P. Russell.  Available from ASQ Quality Audit Division:  www.asq.org (ISBN:  9780873896665, ASQ Item 1263).
Not open to students who have taken Pharmaceutics 494.

5494.  Quality Audit (990) crn:  23272  There is an online section of Quality Audit on Thursday nights.  See the Online Course Schedule for details.  You must use the Registration Form for Online Courses for this class. CLOSED. SEE NEW SECTION ADDED BELOW.

5494.  Quality Audit (991) crn:  23433  There is an online section of Quality Audit on Tuesday nights.  See the Online Course Schedule for details.  You must use the Registration Form for Online Courses for this class.

5495.  IND/NDA Submissions (101) crn: 23266
Prerequisite:  Drug Development (Pharmaceutics 5459) or Food and Drug Law I (Pharmaceutics 5592).
8:30 am - 5:00 pm (1 hour lunch) Sundays:  Jan 26, Feb 9, 23, Mar 9, 23.  Meets 5 times plus final exam.  Make-ups, if needed, Apr 6 or 13.  Proctored, in-class exams:  Feb 23 and Mar 23.
Faculty:  L. Edwards
Required text: New Drug Development: A Regulatory Overview, Mathieu, 8th ed, (ISBN: 1-882615-85-9).
Other materials to be provided by the instructor.
Not open to students who have taken Pharmaceutics 495.

Tarrytown
5495.  IND/NDA Submissions (318)  crn: 23267
This class meets in Tarrytown, NY, by the Tappan Zee Bridge.
Prerequisite:  Drug Development (Pharmaceutics 5459) or Food and Drug Law I (Pharmaceutics 5592).
8:30 am - 5:00 pm Saturdays (1 hour lunch):  Jan 25, Feb 8, 22, Mar 8, 22.  Meets 5 times plus final exam.  Make-up, if needed, Apr 5.  Proctored, in-class exam:  Feb 22.
Faculty:  A. Traettino
Required text: New Drug Development: A Regulatory Overview, Mathieu, 8th ed, (ISBN: 1-882615-85-9).
Not open to students who have taken Pharmaceutics 495.

5495.  IND/NDA Submissions (990)  crn:  20675  There is an online section of IND/NDA Submissions on Tuesday nights.  See the Online Course Schedule for details.  You must use the Registration Form for Online Courses for this class. CLOSED. WAIT LIST ONLY.

5496.  Regulation of Medical Devices:  Compliance (990)  crn:  23273  There is an online section of Regulation of Medical Devices:  Compliance on Monday nights.  See the Online Course Schedule for details.  You must use the Registration Form for Online Courses for this class.

5498.  Computer Validation (990)  crn:  23275  There is an online section of Computer Validation on Monday nights.  See the Online Schedule of Courses for details.  You must use the Registration Form for Online Courses for this class.

5502.  Medical Device Regulation:  Submissions (990)  crn:  20666  There is an online section of Medical Device Regulation:  Submissions on Thursday nights.  See the Online Schedule of Courses for details.  You must use the Registration Form for Online Courses for this class.

5513.  Active Pharmaceutical Ingredients (APIs) (990) crn:  20741  There is an online section of Active Pharmaceutical Ingredients (APIs) on Wednesday nights.  See the Online Schedule of Courses for details.  You must use the Registration Form for Online Courses for this class.

5515.  Biologics/Biosimilars:  A Regulatory Overview (990)  crn:  20655  There is an online section of Biologics/Biosimilars on Monday nights.  See the Online Schedule of Courses for details.  You must use the Registration Form for Online Courses for this class. CLOSED. WAIT LIST ONLY.

5532.  Global Labeling Regulation:  Principles and Practices (101) crn:  20658 
Prerequisite:  either Drug Development (Pharmaceutics 5459) or Food and Drug Law I (Pharmaceutics 5592).
8:30 am – 3:00 pm Saturdays (1/2 hour lunch): Jan 18, Feb 1, 15, Mar 1, 15, 29.  Meets 6 times plus final exam.  Make-up, if needed, Apr 12.  Proctored, in-class exam:  Mar 29. 
Faculty:  B. Fanelli and G. Jan-Nijeldt
No required text.

5536.  Good Clinical Practices (990)  crn:  23276  There is an online section of Good Clinical Practices on Wednesday nights.  See the Online Schedule of Courses for details.  You must use the Registration Form for Online Courses for this class.

5537. Clinical Trial Management (990) crn: 20667 An online section of Clinical Trial Management has just been added on Monday nights. See the Online Schedule of Courses for details. You must use the Registration Form for Online Courses for this class.

5544.  Regulatory Intelligence (101)  crn: 20795
Prerequisites: Drug Development (Pharmaceutics 5459) and Food and Drug Law I (Pharmaceutics 5592).
8:30 am – 4:30 pm Sundays (1/2 hour lunch):  Jan 19, Feb 2, 16, Mar 2, 16.  Meets 5 times plus final exam.  Make-ups, if needed, Apr 13.  Proctored, in-class quizzes:  Feb 16 and Mar 2.
Faculty:  L. Bowen
No required text.

5547.  Project Management for Clinical Trials (990) crn:  20669  There is an online section of Project Management for Clinical Trials on Thursday nights.  See the Online Schedule of Courses for details.  You must use the Registration Form for Online Courses for this class.
                                                     
5578.  Benefit Risk Management and Safety Signaling of Healthcare Products (990)  crn:  8723 There is an online section of Benefit Risk Management and Safety Signaling of Healthcare Products on Thursdays. See the Online Schedule of Courses for details.  You must use the Registration Form for Online Courses for this class.

5579.  Regulatory and  Legal Basis of Pharmacovigilance (101)  crn: 23269
Special Note:  this course is offered in both a traditional classroom format and online.
6:00 pm - 9:00 pm Tuesdays:  Jan 28, Feb 4, 11, 18, 25, Mar 4, 11, 18, 25, Apr 1, 8, 15, 22 (proctored, in-class exam).  Meets 12 times plus final exam.  Make-up, if needed, Apr 29.  Proctored, in-class exam:  Apr 22.
Faculty:  D. Wallace
Suggested text:  Pharmacovigilance, Ronald D. Mann, Elizabeth B. Andrews, 2007, John Wiley & Sons, 2nd ed.
Suggested prerequisite:  one Pharmacovigilance course: Post Marketing Safety Surveillance (Pharmaceutics 5571) or Clinical Drug Safety and Pharmacovigilance (Pharmaceutics 5538) or Good Pharmacovigilance Operations (Pharmaceutics 5508) or Benefit-Risk Management and Safety Signaling of Healthcare Products (Pharmaceutics 5578).

5579.  Regulatory and Legal Basis of Pharmacovigilance (990) crn:  20670  There is an online section of Regulatory and Legal Basis of Pharmacovigilance on Tuesdays. See the Online Schedule of Courses for details.  You must use the Registration Form for Online Courses for this class.

5591.  Global Regulatory Affairs (990) crn: 20671 There is an online section of Global Regulatory Affairs on Wednesdays. See the Online Schedule of Courses for details.  You must use the Registration Form for Online Courses for this class.

5592.  Food and Drug Law I (101)  crn: 2190 
To learn more: http://qara-apache.temple.edu/hammes/chfdlaw.html
8:30 am – 3:00 pm Sundays (1/2 hour lunch):  Jan 26, Feb 9, 23, Mar 9, 23, Apr 6.  Meets 6 times plus final exam.  Make-ups, if needed, Apr 27.  Proctored, in-class exam:  Feb 23.
Faculty:  C. Hammes
Note:  Since this class only meets 6 times, there is required reading for the first class.  Please purchase the textbooks in advance and bring them to class. Read pp 1 – 27 of Hutt’s Food and Drug Law:  Cases and Materials. Please also download the U.S. Constitution and bring it to the first class:  http://www.archives.gov/exhibits/charters/constitution_transcript.html
Required texts:  1) Food and Drug Law: Cases and Materials, 3rd ed, Hutt, et al, Foundation Press, (ISBN: 978-1-58778-068-4).  Make sure you purchase the 2007 edition (and not earlier editions); and 2) Statutory Supplement, Hutt, West Academic Publishing(ISBN: 9781609302108).
Not open to students who have taken Pharmaceutics 592.

5592.  Food and Drug Law I (102)  crn: 20660
To learn more:  http://qara-apache.temple.edu/BBerger/BBFDLaw1.html
8:30 am – 3:00 pm Saturdays (1/2 hour lunch):  Jan 18, Feb 1, 15, Mar 1, 15, 29.  Meets 6 times plus final exam.  Make-ups, if needed, Apr 5 or 26.  Proctored exam:  Mar 1.
Faculty:  B. Berger
Required texts: 1) Food and Drug Law:  Cases and Materials, 3rd ed, Hutt, et al, Foundation Press, (ISBN: 978-1-58778-068-4).  Make sure you purchase the 2007 edition (and not earlier editions);  and 2) FDCA Statutory Supplement, (ISBN:  978-1-935065-54-8).  Note:  a used 2008 or later edition of the FDCA Statutory Supplement is also acceptable. Order Supplement from www.fdli.org.  FDLI gives QA/RA students a special student discount, only if you order the Supplement by phone from FDLI’s Customer Service Department (1-800-956-6293) or via fax (202-371-0649).  You must include a copy of your Temple QA/RA schedule.  Do not complete the transaction online, or you will be charged non-member prices.
Not open to students who have taken Pharmaceutics 592.

5592.  Food and Drug Law I (103)  crn: 9956 
6:00 pm – 9:30 pm Mondays:  STARTS Feb 17 (Presidents’ Day), 24, Mar 3, 10, 17, 24, 31, Apr 7, Apr 14, 21, 28 (proctored, in-class exam).  Meets 10 times plus final exam.  Make-ups, if needed, May 5.  Proctored, in-class exam:  Apr 28.
Faculty:  B. Bollwage
Required text: Food and Drug Law:  Cases and Materials, 3rd ed, Hutt, et al, Foundation Press, (ISBN: 978-1-58778-068-4). Make sure you purchase the 2007 edition (and not earlier editions).  
Not open to students who have taken Pharmaceutics 592.

5592.  Food and Drug Law I (990) crn:  9424 There is an online section of Food and Drug Law I on Wednesdays. See the Online Schedule of Courses for details.  You must use the Registration Form for Online Courses for this class.

5595. Food Law (990)  crn:  23277 There is an online section of Food Law on Mondays. See the Online Schedule of Courses for details.  You must use the Registration Form for Online Courses for this class.

5601.  Industry Interactions with FDA and Health Authorities (990)  crn:  8726  There is an online section of Food Law on Mondays. See the Online Schedule of Courses for details.  You must use the Registration Form for Online Courses for this class. CLOSED. WAIT LIST ONLY.

5605.  Advanced Topics in Food and Drug Law (990) crn: 23279 There is an online section of Advanced Topics in Food and Drug Law on Tuesday nights. See the Online Schedule of Courses for details.  You must use the Registration Form for Online Courses for this class.

5622.  Unit Operations (101) crn:  20664
This course includes two required workshops to Emerson Resources, where students will practice milling, mixing, tableting and coating. Please reserve all listed dates. Emerson Resources is located at 600 Markley St, #1, Norristown, PA  19401.
8:00 am – 2:30 pm Saturdays (1/2 hour lunch):  Jan 25, Feb 8, 22, Mar 8 (required workshop), 22 (required workshop), Apr 5, April 12 (final exam).  Required all-day workshops to Emerson: Mar 8 and 22. Proctored, in-class exam:  Apr 12. Make-up, if needed, Apr 26. 
Faculty:  W. McVay
Prerequisite:  Strong science background, including a BS in pharmacy, chemistry, biology, or engineering and familiarity with chemistry, biology, and physics.  Students should also have a basic understanding of pharmaceutical manufacturing processes.
Required text:  Pharmaceutical Process Engineering, Hickey and Ganderton, (ISBN: 0-8247-0298-0). Supplemental text:  Pharmaceutical Process Design and Management, K. McCormick, W. McVay, Gower Publishing Ltd, 2012 [ISBN: 978-1-4094-2711-7 (hardback) or 978-1-4094-2712-4 (electronic version)]. Available at ashgate.com/Business (left menu)/Pharmaceutical (right menu).

5627. Statistical Design of Experiments (DOE) (101) crn: 12422
8:30 am - 5:00 pm Saturdays: March 8, 22, Apr 5, 12, Apr 26. Meets five times. Proctored midterm: Apr 5th.
Faculty: R. Snee
Required text: Design and Analysis of Experiments, Douglas C. Montgomery, 2012, 8th ed, (ISBN: 9781118214718).

5655.  Analytical Chemistry in the Pharmaceutical Laboratory (990)  crn:  23278 There is an online section of Analytical Chemistry in the Pharmaceutical Laboratory on Tuesday nights. See the Online Schedule of Courses for details.  You must use the Registration Form for Online Courses for this class.

8005. Pharmaceutical Biotechnology (990)  crn:  20673  There is an online section of Pharmaceutical Biotechnology on Thursday nights.  See the Online Schedule of Courses for details.  You must use the Registration Form for Online Courses for this class.

-------------------------------------------
The following courses are from the non-thesis Pharmaceutics program and require a very strong science background.  This consists of a minimum of 2 years of general chemistry, including organic and one analytical chemistry course.  Students must fax their resume to 267.468.8565 for written permission to register.

8006.  Physical Pharmacy (101)  crn: 23271
6:00 pm - 7:30 pm Tuesdays:  Jan 28, Feb 4, 11, 18, 25, Mar 11, 18, 25, Apr 1, 8, 15, 22 (proctored, in-class exam with 4 hour time limit).  Meets 12 times plus final exam.  Make-up, if needed, Apr 29 or May 6.  Proctored, in-class exam:  April 22 (6:00 pm - 10:00 pm).  No class Mar 4.
In this hybrid course, in-class lectures are supplemented with recordings posted on Blackboard.
Faculty:  D. Lebo
Required text:  Martin’s Physical Pharmacy and Pharmaceutical Sciences, J. Sinko, Lippincoot Williams & Wilkins, 6th ed, (ISBN:  9780781850271).
Not open to students who have taken Pharmaceutics 485.

8007.  Applied Biopharmaceutics (101) crn:  7327
5:30 pm – 8:30 pm Mondays:  Jan 27, Feb 10, 17 (Presidents' Day), 24 (in-class, proctored exam),  Mar 3, 10, 17, 24, 31, Apr 7, 14, 21 (in-class, proctored exam).   Meets 12 times plus final exam.  Make-ups, if needed, Apr 28 or May 5.  Proctored, in-class exams: Feb 24 and Apr 21. Feb 3 class cancelled due to snow storm.
Faculty:  R. Fassihi
No required text.
Not open to students who have taken Pharmaceutics 410.

 

line

Registration Form for Traditional Courses at Fort Washington

Students MUST use the Registration Form for Online Courses for Online Courses.

How to Register

Is this your first registration with Temple? If so, you must include a RESIDENCY FORM

Is this your fourth class with the QA/RA program? If so, you must include a Non-Matriculated Graduate Student Waiver.

Do you want to apply for the MS in QA/RA? Click here to get started.

PRINT AND FAX YOUR FORMS TO: 267.468.8565

You may also email your forms to: qarareg@temple.edu
or, mail your forms to:

Temple University
QA/RA Graduate Program
425 Commerce Drive, Suite 175
Ft. Washington, PA 19034

Order texts on-line via: Virtual Bookstore
 Or, phone: 1.800.325.3252

Drop/Add Policy

To receive a complete refund for a course, you must notify the QA/RA Office in writing that you are dropping BEFORE the second class takes place (weekend courses) or BEFORE the third class takes place (weeknight courses). Please use the Course Withdrawal Form.

QA/RA website

 
Temple University School of Pharmacy
QA/RA Graduate Program

425 Commerce Drive, Suite 175
Fort Washington, PA  19034-2713
Phone: 267.468.8560
E-Mail:
qara@temple.edu