QA/RA Online Course Schedule – Summer 2014 (updated 4/9/14)



Before registering for an online course, please read Expectations of Online Students.

Summer registration is now open. Summer classes will start on Monday, May 12th.

We will process summer registrations starting Tuesday, April 29. No installment plans are available in the summer. Generally payment is due within two weeks of registration. Students must pay in full by the designated due date on their tuition statement to avoid incurring a $60 late fee.

You may hold your spot in the course of your choice by submitting a complete registration form to the QA/RA Office via fax (267.468.8565) or email (qarareg@temple.edu) as soon as possible. Sorry, but your spot will not be held unless your registration information is complete.

New students must include a current copy of their resume, photocopies of transcripts of any universities attended, and a current, electronic (emailed) photograph of themselves.

New international students must also submit a photocopy of their TOEFL scores and WES reports.

To pursue our online courses, students must have a webcam (either built-in or free-standing) and a headset with a built-in microphone. The headset improves the audio quality for all students in the class, so it is mandatory. Please do not register if you are unwilling to purchase these items. If the QA/RA Office learns that you do not have them, your registration will be cancelled, and you will not be permitted to register for future online courses.

You also must have administrative rights to your computer/laptop, since our online platform (Adobe Connect) will automatically install Flashplayer to operate correctly. Many work computers at pharmaceutical companies do not give users administrative rights.

All QA/RA courses, including online classes, require proctored exams. Before you register, make sure you review and understand our 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 (East Coast time) 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. There is a $20.00 charge for any student who requests a change in the proctored exam date. For more information on Proctoring and Fees for Changing Exam Dates, click here.

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

This schedule is subject to change. Please make sure you refresh your Browser (particularly if you use Netscape or Internet Explorer) to make sure you always have the latest version of our schedule.

We are still confirming textbooks for courses. We will post required texts as we receive the information from instructors. Texts may be ordered from the Temple U Ambler Book store (phone: 267-468-8460).

5408.  Pharmacoeconomics (990)  crn:  4157 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
6:00 pm - 9:00 pm Wednesdays:  May 14, 21, 28, June 11, 18, 25, July 2, 9, 16, 23, 30, Aug 6.  No class June 4.  Meets 12 times plus final exam.  Make-up, if needed, Aug 13 or 20.  Proctored exam:  June 25.
Faculty:  A. Naim
Required text:  Principles of Pharmacoeconomics, J.L. Bootman, R. J. Townsend, W.F. McGhan, 3rd ed.
Not open to students who have completed Pharmaceutics 480.

5459. Drug Development  (990) crn:  2539 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
6:00 pm – 9:00 pm Tuesdays:   May 13, 20, 27, June 3, 10, 17, 24, July 1, 8, 15, 22, 29, Aug 5 (proctored final exam).  Meets 12 times plus proctored exam.  Make-ups, if needed, Aug 12 or 19.  Proctored exam:  Aug 5.
Faculty:  J. Parker
Required text:  to be announced.
Not open to students who have taken Pharmaceutics 459.

5473.  Generic Drug Regulation (990)  crn: 4927 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Prerequisite:  Drug Development (Pharmaceutics 5459)
6:00 pm - 9:00 pm  Wednesdays:  May 14, 21, 28, June 4, 11, 18, 25, July 2, 9, 16, 23, 30.  Meets 12 times plus final exam.  Make-ups, if needed, Aug 6 or 13.  Proctored exam:  June 18.
Faculty:  C. Ciliberto
No required text.
Not open to students who have taken Pharmaceutics 483.

5477.  Good Manufacturing Practices (990)  crn:  4136 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
6:00 pm – 9:00 pm Thursdays:  May 15, 22, 29, June 5, 12, 19, 26, July 10, 17, 24, 31, Aug 7.  No class July 3.  Meets 12 times plus final exam.  Make-ups, if needed, Aug 14 or 21.  Proctored exam:  June 26.
Faculty:  E. Boswell
No required text.
Not open to students who have taken Pharmaceutics 487.

5479.  Advanced GMPs - Defining "c"  (990)  crn:  2494 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Special note:  this course will use Software Secure, an online proctoring service that costs $15.00 and enables students to take exams at home.  Students are responsible for paying the $15.00 fee directly to Software Secure. The fee will be charged, even if students use a computer at Temple University, a library, or other location.  If you do not wish to participate in online proctoring, please do not sign up for this course.
Prerequisite:  Good Manufacturing Practices (Pharmaceutics 5477) or at least 5 years of pharmaceutical manufacturing experience.  Fax resume for approval to 267.468.8565.
7:00 pm – 10:00 pm Mondays:  May 12, 19, June 2, 9, 16, 23, 30, July 7, 14, 21, 28, Aug 4.  No class May 26 (Memorial Day).  Meets 12 times plus final exam.  Make-ups, if needed, Aug 11 or 18.  Proctored exam:  June 23.
Faculty:  K. Zimm
No required text.
Not open to students who have taken Pharmaceutics 479.

5494.  Quality Audit (990)  crn:  4137 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Prerequisite:  a good practices course (either Pharmaceutics 5476, 5477, 5479 or 5536).
6:00 pm - 9:00 pm Mondays: May 12, 19, June 2, 9, 16, 23, 30, July 7, 14, 21, 28, Aug 4. Meets 12 times plus final exam. No class May 26. Make-ups, if needed, Aug 11 or 18. In-class, proctored exam: June 23.
Faculty:  J. Goeke
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.

5495.  IND/NDA Submissions (990)  crn:  2531 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Special note:  this course will use Software Secure, an online proctoring service that costs $15.00 and enables students to take exams at home.  Students are responsible for paying the $15.00 fee directly to Software Secure. The fee will be charged, even if students use a computer at Temple University, a library, or other location.  If you do not wish to participate in online proctoring, please do not sign up for this course.
Prerequisite:  Drug Development (Pharmaceutics 5459) or Food and Drug Law I (Pharmaceutics 5592).
6:00 pm – 9:00 pm Mondays:  May 12, 19, June 2, 9, 16, 23, 30, July 7, 14, 21, 28, Aug 4.  No class May 26.  Meets 12 times plus final exam.  Make-ups, if needed, Aug 11 or 18.  Proctored exam:  June 23.
Faculty:  A. Traettino
Required text: to be announced.
Not open to students who have taken Pharmaceutics 495.

5495.  IND/NDA Submissions (991)  crn:  4920 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Special note:  this course will use Software Secure, an online proctoring service that costs $15.00 and enables students to take exams at home.  Students are responsible for paying the $15.00 fee directly to Software Secure. The fee will be charged,, even if students use a computer at Temple University, a library, or other location.  If you do not wish to participate in online proctoring, please do not sign up for this course.
Prerequisite:  Drug Development (Pharmaceutics 5459) or Food and Drug Law I (Pharmaceutics 5592).
6:00 pm – 9:00 pm Thursdays:  May 15, 22, 29,  June 5, 12, 19, 26,  July 10, 17, 24, 31, Aug 7.   No class July 3. Meets 12 times plus final exam.  Make-ups, if needed, Aug 14 or 21.  Proctored exam:  June 19.
Faculty:  A. Traettino
Required text: to be announced.
Not open to students who have taken Pharmaceutics 495.

5502.  Medical Device Regulation:  Submissions (990) crn:  4921 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Special note:  this course will use Software Secure, an online proctoring service that costs $15.00 and enables students to take exams at home.  Students are responsible for paying the $15.00 fee directly to Software Secure. The fee will be charged, even if students use a computer at Temple University, a library, or other location.  If you do not wish to participate in online proctoring, please do not sign up for this course.
6:00 pm – 9:00 pm Wednesdays:  May 14, 21, 28, June 4, 11, 18, 25, July 9, 16, 23, 30, Aug 6.  No class July 2.  Meets 12 times plus final exam.  Make-up, if needed, Aug 13 or 20.  Proctored exam:  June 25.
Faculty:  M. Arentz
No required text.
Not open to students who have taken Pharmaceutics 500.

5516.  Cleaning Validation (990) crn:  3422 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
6:00 pm - 9:00 pm Tuesdays:  May 13, 20, 27, June 3, 10, 17, 24, July 1, 8, 15, 22, 29, Aug 5 (proctored final).  Meets 12 times plus final exam.  Make-ups, if needed, Aug 12 or 19.  Proctored exam:  Aug 5.
Faculty:  R. Forsyth
No required text.

5536.  Good Clinical Practices (990)  crn:  3423 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
6:00 pm - 9:00 pm Thursdays:  May 15, 22, 29, June 5, 12, 19, 26, July 10, 17, 24, 31, Aug 7.  Meets 12 times plus final exam.  No class July 3rd.  Make-ups, if needed, Aug 14 or 21. Proctored exam:  June 26.
Faculty:  J. Scavone
Required text:  to be announced.
Not open to students who have taken Pharmaceutics 536.

5538.  Clinical Drug Safety and Pharmacovigilance (990) crn:  4915 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
7:15 pm - 10:15 pm Mondays:  May 12, 19, June 2, 9, 16, 23, 30, July 7, 14, 21, 28, Aug 4, 11 (proctored final).  No class May 26.  Meets 12 times plus final exam.  Make-up, if needed, Aug 18.  Proctored exam:  Aug 11.
Faculty:  J. Little
Required text: 
Not open to students who have taken Pharmaceutics 538.

5545.  Post Approval Changes (PAC)  (990)  crn:  4923 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Special note:  this course will use Software Secure, an online proctoring service that costs $15.00 and enables students to take exams at home.  Students are responsible for paying the $15.00 fee directly to Software Secure. The fee will be charged, even if students use a computer at Temple University, a library, or other location.  If you do not wish to participate in online proctoring, please do not sign up for this course.
7:00 pm - 10:00 pm Thursdays:  May 15, 22, 29, June 5, 12, 19, 26, July 10, 17, 24, 31, Aug 7.  No class July 3.  Meets 12 times plus final exam.  Make-ups, if needed, Aug 14 or 21. Procotred exam: June 19.
Faculty:  K Zimm.
No required text.
Not open to students who have completed Pharmaceutics 545.

5546.  Global Pharmaceutical Excipient Regulation (990)  crn:  4139 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Special note:  this course will use Software Secure, an online proctoring service that costs $15.00 and enables students to take exams at home.  Students are responsible for paying the $15.00 fee directly to Software Secure. The fee will be charged, even if students use a computer at Temple University, a library, or other location.  If you do not wish to participate in online proctoring, please do not sign up for this course.
6:00 pm - 9:00 pm Tuesdays:  May 13, 20, 27, June 3, 10, 17, 24, July 1, 8, 15, 22, 29.  Meets 12 times plus final exam.  Make-ups, if needed, Aug 5 or 12.  Proctored exam:  June 24
Faculty:  A. Smith
No required text.
Not open to students who have completed Pharmaceutics 546.

5571.  Post Marketing Safety Surveillance (990) crn:   4159 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Special Note:  this course is offered in both a traditional classroom format and online.
6:00 pm - 9:00 pm Tuesdays:  May 13, 20, 27, June 3, 10, 17, 24, July 1, 8, 15, 22, 29, Aug 5 (proctored final).  Meets 12 times plus final exam.  Make-up, if needed, Aug 12.  Proctored exam:  Aug 5.
Faculty:  D. Wallace
Suggested text:  Practical Aspects of Signal Detection in Pharmacovigilance, CIOMS Group VIII, 2010. Available from CIOMS at: http://apps.who.int/bookorders/anglai/detart1.jsp?sesslan=1&codlan=1&codcol=84&codcch=30
Optional text:  Pharmacovigilance, Andrews and Mann, 2007, Wiley & Sons, Inc., (ISBN:  0470018038).
Not open to students who have taken Pharmaceutics 571.

5576.  Global CMC Issues and the Regulatory Dossier (990)  crn: 4922 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
6:00 pm - 9:00 pm Mondays:  May 12, 19, June 2, 9, 16, 23, 30, July 7, 14, 21, 28, Aug 4.  Meets 12 times plus final exam.  No class May 26.  Make-ups, if needed, Aug 11 or 18.  Proctored exam:  June 30.
Faculty:  F. Diana
Required text:  to be announced
Not open to students who have taken Pharmaceutics 586.

5591.  Global Regulatory Affairs (990)  crn: 1733 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Special note:  this course will use Software Secure, an online proctoring service that costs $15.00 and enables students to take exams at home.  Students are responsible for paying the $15.00 fee directly to Software Secure. The fee will be charged,, even if students use a computer at Temple University, a library, or other location.  If you do not wish to participate in online proctoring, please do not sign up for this course.
Prerequisite:  Drug Development (Pharmaceutics 5459) or Food and Drug Law I (Pharmaceutics 5592).
6:00 pm – 9:00 pm Thursdays:  May 15, 22, 29, June 5, 12, 19, 26, July 10, 17, 24, 31, Aug 7.  No class July 3.  Meets 12 times plus final exam.  Make-ups, if needed, Aug 14 or 21.  Proctored exam:  June 19.
Faculty:  D. Larkins
No required text.
Not open to students who have completed Pharmaceutics 591.

5592.  Food and Drug Law I (990)  crn:  1734 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
To learn more: https://breeze.temple.edu/p11528886/
6:00 pm – 9:00 pm Wednesdays:  May 14, 21, 28, June 4, 11, 18, 25, July 2, 9, 16, 23, 30.  Meets 12 times plus final exam.  Make-ups, if needed, Aug 6 or 13.  Proctored exam:  June 18.
Faculty:  G. Pilgrim
Required text: to be announced.
Recommended text:  Statutory Supplement, Hutt, West Academic Publishing(ISBN: 9781609302108).
Not open to students who have taken Pharmaceutics 592.

5596. Food Labeling and Regulatory Affairs (990)  crn:  4160  Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
6:30 pm - 9:30 pm Wednesdays:  May 14, 21, 28, June 4, 11, 18, 25, July 2, 9, 16, 23, 30, Aug 6 (proctored final exam). Meets 12 times plus proctored final exam. Make-ups, if needed, Aug 13 or 20. Proctored exam: Aug 6.
Faculty:  K. Sooter
No required text.                                    

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Students MUST use the Registration Form 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: Temple University Ambler Bookstore

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.

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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