QA/RA Online Course Schedule – Fall 2013 (updated 9/10/13)


Notes:
Our fall semester has started. Fall registration is still OPEN. Please send your registration form for fall classes now, if you haven't done so already. Many online courses have closed, but you can still send in your registration form, in case a spot opens up.

Fall tuition bills will be generated about two weeks after we process your registration and will be due October 16th. If you don't pay your bill by the due date, you will incur a $60 late payment fee.

You must purchase a headset with a built-in microphone and a webcam for any online course. You must test the headset and web cam for compatibility with our online course platform. Both of these items will enhance your class presentations and participation.

You must have any stated prerequisites to register for Online courses.

All students new to Temple QA/RA Online courses must watch:   http://breeze.temple.edu/p59716030. A password is given at the end, which you must include on your registration form. We will not process registration forms that do not have the password.  If you have previously taken a Temple U QA/RA online course, you do not need to take the self-test of Adobe, unless you have recently changed laptops or computers. If you plan to use a different computer, please be considerate of other members in your class and TEST your new computer BEFORE starting a class.

All Online courses have limited seats. Registration is first-come, first-served.

Please make sure you review and understand the SOPs for proctoring in online courses. This includes agreeing to take your midterm or final during the window of 3:00 pm - 9:00 pm on the designated exam date (no exceptions). Due to University academic policies, the QA/RA Office will not allow students to alter exam dates, so please adjust your schedule accordingly for the proctored exam in your course. For more on Proctoring, click here.

New students: Please remember to include a copy of your resume, the state residency form, copies of college transcripts, and TOEFL scores and WES reports (if applicable) with your initial registration. New students must also submit a recent photograph of themselves for identification purposes. This can be submitted hard copy or electronically.

CLASSES ARE LISTED IN EAST COAST TIMES (please adjust according to your time zone).

Fall 2013 - Semester begins September 7, 2013

JUST ADDED!

For those interested in the Pharmcovigilance Certificate:

5573.  Pharmacoepidemiology (990)  crn:  23784
5:30 pm - 8:30 pm Tues: Sept 17, 24, Oct 1, 8, 15, 22, 29, Nov 5, 12, 19, 26, Dec 3.  Meets 12 times plus final. See below for more details

 

5459. Drug Development  (990) crn: 17910 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
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 or 10. Proctored exam: Oct 22.
Faculty:  D. Walsh
Three required texts:  1) New Drug Development:  A Regulatory Overview, Mathieu, 8th ed, (ISBN: 1-882615-85-9);  2) Drugs:  From Discovery to Approval, Ng, 2nd ed, Dec 2008, Wiley-Blackwell, (ISBN: 978-0-470-19510-9); AND 3) The Great Influenza:  The Epic Story of the Deadliest Plague in History, John M. Barry, Penguin Group, Oct 2005, (ISBN: 13-9780143036494).
Formerly Pharmaceutics 459.  Not open to students who have taken Pharmaceutics 459.

5459. Drug Development (991) crn:  7407 Expectations of Online Students. You must use the Registration Form for Online Courses for this class. CLOSED. WAIT LIST ONLY. SEE TUESDAY SECTION ABOVE (which is still open).
6:00 pm – 9:00 pm Mondays:  Sept 9, 16, 23, 30, Oct 7, 14 (Columbus Day), 21, 28, Nov 4, 11 (Veteran's Day), 18, 25.  Meets 12 times plus final exam.  Make-ups, if needed, Dec 2 or 9.  Proctored exam:  Oct 14.
Faculty:  A. Traettino
Required text:  New Drug Development: A Regulatory Overview, Mathieu, 8th ed., (ISBN:  1-882615-85-9).
Formerly Pharmaceutics 459.  Not open to students who have taken Pharmaceutics 459.

5473.  Generic Drug Regulation: ANDAs (990) crn: 20853 Expectations of Online Students. You must use the Registration Form for Online Courses for this class. CLOSED. WAIT LIST ONLY.
Prerequisite:  Drug Development (Pharmaceutics 5459).
6:00 pm – 9:00 pm Wednesdays:  Sept 11, 18, 25, Oct 2, 9, 16, 23, 30, Nov 6, 13, 20, Dec 4. Meets 12 times plus final exam. Make-ups, if needed, Dec 11 or 18.  Proctored exam:  Oct 23. No class Nov 27.
Faculty:  C. Ciliberto
No required text.
Formerly Pharmaceutics 483.  Not open to students who have taken Pharmaceutics 483.

5476.  Good Laboratory Practices (990) crn: 23411 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
6:00 pm - 9:00 pm Mondays:  Sept 9, 16, 23, 30, Oct 7, 14 (Columbus Day), 21, 28, Nov 4, 11 (Veteran's Day), 18, 25.  Meets 12 times plus final exam.  Make-ups, if needed, Dec 2 or 9.  Proctored exam: Oct 28.
Faculty:  J. Goeke
Required text:  to be announced
Formerly Pharmaceutics 486.  Not open to students who have taken Pharmaceutics 486.

5477.  Good Manufacturing Practices (990) crn: 9357 Expectations of Online Students. You must use the Registration Form for Online Courses for this class. CLOSED. WAIT LIST ONLY.
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 or 10.  Proctored midterm:  Oct 15.
Faculty:  E. Boswell
Required text: Good Manufacturing Practices for Pharmaceutics, Nally, 6th ed, (ISBN:  0-8493-3972-3).
Formerly Pharmaceutics 487.  Not open to students who have taken Pharmaceutics 487.

5495.  IND/NDA Submissions (990)  CLOSED. WAIT LIST ONLY. crn: 23434 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Prerequisite:  Drug Development (Pharmaceutics 5459) or Food and Drug Law I (Pharmaceutics 5592).
6:00 pm – 9:00 pm Thursdays:  Sept 12, 19, 26, Oct 3, 10, 17, 24, 31, Nov 7, 14, 21, Dec 5.  Meets 12 times plus final exam.  Make-ups, if needed, Dec 12 or 19.  Proctored exam:  Oct 17.
Faculty:  A. Traettino
Required text:  New Drug Development:  A Regulatory Overivew, Mathieu, 8th ed., (ISBN:  1-882615-85-9).
Formerly Pharmaceutics 495.  Not open to students who have completed Pharmaceutics 495.

5495.  IND/NDA Submissions (991) crn: 23680 CLOSED. WAIT LIST ONLY. Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Prerequisite:  Drug Development (Pharmaceutics 5459) or Food and Drug Law I (Pharmaceutics 5592).
6:00 pm – 9:00 pm Thursdays:  Sept 12, 19, 26, Oct 3, 10, 17, 24, 31, Nov 7, 14, 21, Dec 5.  Meets 12 times plus final exam.  Make-ups, if needed, Dec 12 or 19.  Proctored exam:  Oct 24.
Faculty:  A. Smith
Required text:  New Drug Development:  A Regulatory Overivew, Mathieu, 8th ed., (ISBN:  1-882615-85-9).
Formerly Pharmaceutics 495.  Not open to students who have completed Pharmaceutics 495.

5502.  Regulation of Medical Devices:  Submissions (990)  crn: 23452 Expectations of Online Students. You must use the Registration Form for Online Courses for this class. CLOSED. WAIT LIST ONLY.
6:00 pm - 9:00 pm Thursdays:  Sept 12, 19, 26, Oct 3, 10, 17, 24, 31, Nov 7, 14, 21, Dec 5.  Meets 12 times plus final exam.  No class Nov 28.  Make-ups, if needed, Dec 12 or 19. Proctored exam:  Oct 24.
Faculty:  M. Arentz
No required text.
Formerly Pharmaceutics 502.  Not open to students who have completed Pharmaceutics 502.

5505.  Global Medical Device Regulation (990) crn: 20855 Expectations of Online Students. You must use the Registration Form for Online Courses for this class. CLOSED. WAIT LIST ONLY.
6:30 pm – 9:30 pm Mondays:  Sept 9, 16, 23, 30, Oct 7, 14, 21, 28, Nov 4, 11 (Veteran's Day), 18, 25.  Meets 12 times plus final exam.  Make-ups, if needed, Dec 2 or 9.  Proctored exam:  Oct 21 (tentative).
Faculty:  M. Arentz
No required text.
Formerly Pharmaceutics 505.  Not open to students who have taken Pharmaceutics 505.

5516.  Cleaning Validation (990)  crn: 23430 Expectations of Online Students. You must use the Registration Form for Online Courses for this class. ALMOST CLOSED.
7:00 pm - 10:00 pm Thursdays:  Sept 12, 19, 26, Oct 3, 10, 17, 24, 31, Nov 7, 14, 21, Dec 5.  Meets 12 times plus final exam.  No class Nov 28 (Thanksgiving).  Make-ups, if needed, Dec 12 or 19.  Proctored exam:  Dec 12.
Faculty:  R. Forsyth
No required text.

5536.  Good Clinical Practices (990) crn:  9358 Expectations of Online Students. You must use the Registration Form for Online Courses for this class. CLOSED. WAIT LIST ONLY.
6:00 pm – 9:00 pm Thursdays:  Sept 12, 19, 26, Oct 3, 10, 17, 24, 31 (Halloween), Nov 7, 14, 21, Dec 5.  Meets 12 times plus final exam.  Make-ups, if needed, Dec 12 or 19.  No class Nov 28 (Thanksgiving). Proctored midterm: Oct 17.
Faculty:  D. Weiss
Required text:  2010 CFR/ICH GCP Reference Guide.  Order from www.barnettinternational.com.  Students may use the 2005/06 version or any subsequent version.
Formerly Pharmaceutics 536.  Not open to students who have taken Pharmaceutics 536.

5537.  Clinical Trial Management (990)  crn: 23438  Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Prerequisite:  Good Clinical Practices (5536) or special permission of the QA/RA department (fax resume to 267.468.8565).
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 or 10.  Proctored exam:  Oct 22. 
Faculty:  J. Scavone
No required text.
Formerly Pharmaceutics 537.  Not open to students who have taken Pharmaceutics 537.

5538.  Clinical Drug Safety and Pharmacovigilance (990)  crn: 17920 Expectations of Online Students. You must use the Registration Form for Online Courses for this class. CLOSED. WAIT LIST ONLY.
Suggested prerequisite:  Drug Development (Pharmaceutics 5459).
7:00 pm – 10:00 pm Mondays:  Sept 9, 16, 23, 30, Oct 7, 14 (Columbus Day), 21, 28, Nov 4, 11 (Veterans' Day), 18, 25. Meets 12 times plus final exam.  Make-ups, if needed, Dec 2 or 9.  Proctored exam: Dec 9.
Faculty:  J. Little
Required text: Manual of Drug Safety and Pharmacovigilance, Barton Cobert, (ISBN:  0763791598 or 9780763791599).
Formerly Pharmaceutics 538.  Not open to students who have taken Pharmaceutics 538.

5545.  Post Approval Changes (990) crn:  23440 Expectations of Online Students. You must use the Registration Form for Online Courses for this class. CLOSED. WAIT LIST ONLY. NOTE: This course will probably be using online proctoring for the Oct 14th midterm. Students must be willing to use the online proctoring platform which will cost $15.00 per exam. Students also have the option of taking their exam at an official testing site or at the Ft Washington Campus.
7:00 pm - 10:00 pm Mondays:  Sept 9, 16, 23, 30, Oct 7, 14 (Columbus Day), 21, 28, Nov 4, 11 (Veteran's Day), 18, 25.  Meets 12 times plus final exam.  Make-ups, if needed, Dec 2 or 9.  Proctored exam:  Oct 14.
Faculty:  K. Zimm
No required text.
Formerly Pharmaceutics 545.  Not open to students who have completed Pharmaceutics 545.

5573.  Pharmacoepidemiology (990)  crn:  23784
5:30 pm - 8:30 pm Tuesdays:  Sept 17, 24, Oct 1, 8, 15, 22, 29, Nov 5, 12, 19, 26, Dec 3.  Meets 12 times plus final exam. Make-up, if needed, Dec 10.  In-class, proctored exam:  Oct 15 (tentative).
Faculty:  J. Cies
Required text:  to be announced.

5576.  Global CMC Issues and Regulatory Dossiers (990) crn: 23441 Expectations of Online Students. You must use the Registration Form for Online Courses for this class. CLOSED. WAIT LIST ONLY.
6:00 pm - 9:00 pm Thursdays:  Sept 12, 19, 26, Oct 3, 10, 17, 24, 31, Nov 7, 14, 21, Dec 5.  Meets 12 times plus final exam. No class Nov 28.  Make-ups, if needed, Dec 12 or 19. Proctored exam:  Oct 24.
Faculty:  S. Modi
No required text.
Formerly Pharmaceutics 586.  Not open to students who have taken Pharmaceutics 586.

5591.  Global Regulatory Affairs (990) crn: 23442 CLOSED. WAIT LIST ONLY. Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Prerequisite:  Drug Development (Pharmaceutics 5459) or Food and Drug Law I (Pharmaceutics 5592).
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 or 10. Proctored exam:  Oct 15.
Faculty:  D. Larkins
No required text.
Formerly Pharmaceutics 591.  Not open to students who have completed Pharmaceutics 591.

5592.  Food and Drug Law I (990) crn: 7202 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
To learn more: https://breeze.temple.edu/p11528886/
CLOSED. WAIT LIST ONLY. Another section has been added (see next course).
6:00 pm – 9:00 pm Wednesdays:  Sept 11, 18, 25, Oct 2, 9, 16, 23, 30, Nov 6, 13, 20, Dec 4.  Meets 12 times plus final exam. Make-ups, if needed, Dec 11 or 18. Proctored exam:  Oct 16. No class Nov 27.
Faculty:  G. Pilgrim
Required text: Food and Drug Law: Cases and Materials, 3rd ed, Hutt, et al, Foundation Press, 2007, (ISBN: 978-
1-58778-068-4). Order the 2007 edition and not earlier versions.
Formerly Pharmaceutics 592.  Not open to students who have taken Pharmaceutics 592.

5592.  Food and Drug Law I (991) crn: 23754  Expectations of Online Students. You must use the Registration Form for Online Courses for this class. To learn more: http://qara-apache.temple.edu/dronitsky/mdfdlaw.html CLOSED. WAIT LIST ONLY.
6:00 pm – 9:00 pm Wednesdays:  Sept 11, 18, 25, Oct 2, 9, 16, 23, 30, Nov 6, 13, 20, Dec 11.  Meets 12 times plus final exam. Make-ups, if needed, Dec 18. Proctored exam:  Oct 16. No class Nov 27.
Faculty: M. Dronitsky
Required text: Food and Drug Law: Cases and Materials, 3rd ed, Hutt, et al, Foundation Press, 2007, (ISBN: 978-
1-58778-068-4). Order the 2007 edition and not earlier versions.
Formerly Pharmaceutics 592.  Not open to students who have taken Pharmaceutics 592.

5612.  Bioethics for Pharmaceutical Professionals (990) crn: 20858 Expectations of Online Students. You must use the Registration Form for Online Courses for this class. CLOSED. WAIT LIST ONLY.
To learn more: https://breeze.temple.edu/p49353203/
6:00 pm – 9:00 pm Wednesday:  Sept 11, 18, 25, Oct 2, 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 or 18.  Proctored exam:  Oct 23.
Faculty:  E. Weringer
Required text:  Bioethics:  An Introduction to the History, Methods, and Practice, Jecker, 3rd ed, 2007, Jones & Bartlett Learning, (ISBN: 1-4496-3586-5).
Formerly Pharmaceutics 610.  Not open to students who have taken Pharmaceutics 610.


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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