QA/RA Online Course Schedule – Summer 2013 (updated 6/3/13)


Notes:
All QA/RA students taking Adobe Connect courses are required to purchase a headset with a built-in microphone, and you must test the headset for compatibility with the Adobe Connect.

You are also required to have a webcam for your computer/laptop. Webcams enhance student presentations and help you to network with other students in your class.

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 must be included on the 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 alter exam times or dates, so please adjust your schedule accordingly for the proctored exam in your course. For more on Proctoring, click here.

To register, please scroll to the bottom of this page and download the Registration Form for Online Courses. You must use this form for an Adobe Connect course.

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 Adobe Connect/WebEx registration. Starting this semester, we are also requiring new students to 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).

Summer 2013 - Semester begins May 13, 2013

 

5408.  Pharmacoeconomics (990)  crn: 4157 Expectations of Online Students. You must use the Registration Form for Online Courses for this course.
6:00 pm - 9:00 pm Wednesdays:  May 15, 22, 29, June 5, 12, 19, 26, July 10, 17, 24, 31, Aug 7.  Meets 12 times plus final exam.  Proctored exam:  June 19.  Make-ups, if needed, Aug 14 or 21. No class July 3. 
Faculty:  Ahmad Naim
Required text: Principles of Pharmacoeconomics, J.L. Bootman, R. J. Townsend, W.F. McGhan, 3rd ed.
Formerly Pharmarceutics 480.  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 course.
6:00 pm – 9:00 pm Tuesdays:  May 14, 21, 28, June 4, 11, 18, 25, July 2, 9, 16, 23, 30.  Meets 12 times plus final exam.  Make-up, if needed Aug  6 or 13.  Proctored midterm: June 25.
Faculty:  Cynthia Ciliberto
Required text:  New Drug Development:  A Regulatory Overview, Mathieu, revised 8th edition, (ISBN: 13: 978-0-9883144-0-5: ). 
Formerly Pharmaceutics 459.  Not open to students who have taken Pharmaceutics 459.

5477.  Good Manufacturing Practices (GMPs) (990)  crn: 4136 Expectations of Online Students. You must use the Registration Form for Online Courses for this course.
7:00 pm - 10:00 pm Mondays:  May 13, 20, June 3, 10, 17, 24, July 1, 8, 15, 22, 29, Aug 5.  Meets 12 times plus final exam.  No class May 27 (Memorial Day).  Make-ups, if needed, Aug 12 or 19.  Proctored exam:  June 24.
Faculty:  Karen Zimm
No required text.
Formerly Pharmaceutics 487.  Not open to students who have taken Pharmaceutics 487.

5472.  Pharmaceutical Marketing (990)  crn: 4158 Expectations of Online Students. You must use the Registration Form for Online Courses for this course.
6:00 pm - 9:00 pm Tuesdays:   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: July 2.
Faculty:  Doug Hisey
Required text:  Pharmaceutical Marketing Principles:  Environment and Practice, Smith, (ISCH: 0789015838).
Formerly Pharmaceutics 482.  Not open to students who have taken Pharmaceutics 482.

5479.  Advanced GMPs – defining “c” (990) crn:  2494 Expectations of Online Students. You must use the Registration Form for Online Courses 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 Thursdays:  May 16, 23, 30, June 6, 13, 20, 27, July 11, 18, 25, Aug 1, 8.  Meets 12 times plus final exam.  No class July 4. Make-ups, if needed, Aug 15 or 22. Proctored midterm:  June 27.
Faculty:  Karen Zimm
No required text.
Formerly Pharmaceutics 479.  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 course.
Prerequisite:  a good practices course (Pharmaceutics 5476, 5477, 5479 or 5536).
6:30 pm - 9:30 pm Thursdays:  May 16, 23, 30, June 6, 13, 20, 27, July 11, 18, 25, Aug 1, 8, 15 (final exam).  Meets 12 times, plus proctored final exam on Aug 15. No class July 4 (Independence Day).  Make-ups, if needed, Aug 22 or 29.
Faculty:  Sarah Van Valkenburg
Required text:  The ASQ Quality Auditing Handbook, 3rd ed, J.P. Russell, (ISBN:  9780873896665).  Order from:  www.asq.org .
Formerly Pharmaceutics 494.  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 course.
Prerequisite:  Drug Development (Pharmaceutics 5459) or Food and Drug Law (Pharmaceutics 5592).
6:00 pm - 9:00 pm Mondays:  May 13, 20, June 3, 10, 17, 24, July 1, 8, 15, 22, 29, Aug 5.  Meets 12 times plus final exam.  No class May 27 (Memorial Day).  Make-ups, if needed, Aug 12 or 19.  Proctored exam:  July 1.
Faculty:  Alan Traettino
Required text:  New Drug Development, A Regulatory Overview, Mathieu, revised 8th edition, (ISBN: 13: 978-0-9883144-0-5).
Formerly Pharmaceutics 495.  Not open to students who have completed Pharmaceutics 495.

5496.  Regulation of Medical Devices:  Compliance (990) crn: 4138 Expectations of Online Students. You must use the Registration Form for Online Courses for this course.
6:00 pm - 9:00 pm Wednesdays:  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 3.  Make-ups, if needed, Aug 14 or 21.  Proctored exam:  June 26.
Faculty:  Marcia Arentz
No required text.
Formerly Pharmaceutics 496.  Not open to students who have taken Pharmaceutics 496.

5505.  Global Medical Device Regulation (990) crn: 2532 Expectations of Online Students. You must use the Registration Form for Online Courses for this course.
6:00 pm – 9:00 pm Mondays:  May 13, 20, June 3, 10, 17, 24, July 1, 8, 15, 22, 29, Aug 5.  Meets 12 times plus final exam. No class May 27 (Memorial Day). Make-ups, if needed, Aug 12 or 19. Proctored exam: July 1. 
Faculty:  Marcia Arentz
No required text.
Formerly Pharmaceutics 505.  Not open to students who have taken Pharmaceutics 505.

5516.  Cleaning Validation (990) crn: 3422 Expectations of Online Students. You must use the Registration Form for Online Courses for this course.
6:00 pm – 9:00 pm Tuesdays:  May 14, 21, 28, June 4, 11, 18, 25, July 2, 9, 16, 23, 30, Aug 6.  Meets 12 times plus proctored final exam.  Make-ups, if needed, Aug 13 or 20.  Proctored exam:  Aug 6.
Faculty:  Richard 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 course.
6:00 pm - 9:00 pm Wednesdays:  May 15, 22, 29, June 5, 12, 19, 26, July 10, 17, 24, 31, Aug 7.  Meets 12 times, plus proctored final exam.  No class July 3.  Make-ups, if needed, Aug 21 or 28.  Proctored exam:  Aug 14.
Faculty:  Michael McGraw
Required text: Principles of Good Clinical Practice, McGraw, George, Shearn, Hall, Haws (editors), Pharmaceutical Press, July 2010, (ISBN-10:0853697906, ISBN-13:978-0853697909). 
Formerly Pharmaceutics 536.  Not open to students who have taken Pharmaceutics 536.

5546.  Global Pharmaceutical Excipient Regulation (990) crn: 4139 Expectations of Online Students. You must use the Registration Form for Online Courses for this course.
6:00 pm - 9:00 pm Tuesdays:  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 25.
Faculty:  Alexa Smith
No required text.
Formerly Pharmaceutics 546.  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 course.
6:00 pm - 9:00 pm Mondays:  May 13, 20, June 3, 10, 17, 24, July 1, 8, 15, 22, 29, Aug 5.  Meets 12 times plus final exam on Aug 12.  No class May 27 (Memorial Day).  Make-ups, if needed, Aug 19 or 26.  Proctored exam: Aug 12
Faculty:  Don Wallace
Required text:  Practical Aspects of Signal Detection in Pharmacovigilance, CIOMS Group VIII, 2010,
http://apps.who.int/bookorders/anglais/detart1.jsp?sesslan=1&codlan=1&codcol=84&codcch=30
Optional text: Pharmacovigilance, Andrews and Mann, 2007, Wiley & Sons, Inc., (ISBN: 0470018038).
Formerly Pharmaceutics 571.  Not open to students who have taken Pharmaceutics 571.

5591. Global Regulatory Affairs (990) crn:  1733 Expectations of Online Students. You must use the Registration Form for Online Courses for this course.
Prerequisite:  Drug Development (Pharmaceutics 5459) or Food and Drug Law I (Pharmaceutics 5592).
6:00 pm – 9:00 pm Thursdays:  May 16, 23, 30, June 6, 13, 20,  27, July 11, 18, 25, Aug 1, 8.  Meets 12 times plus final exam.  Make-ups, if needed Aug 15 or 22.  No class July 4.  Proctored midterm:  June 20.
Faculty:  Dan Larkins
No required text.
Formerly Pharmaceutics 591.  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 course.
6:00 pm – 9:00 pm Wednesdays:  May 15, 22, 29, June 5, 12, 19, 26, July 3 (recorded lecture that students have one week to view) 10, 17, 24, 31.  Meets 12 times plus final exam.   Make-ups, if needed, Aug 14 or 21.  Proctored exam:  June 19.
Faculty:  Gail Pilgrim
Required text: Food and Drug Law: Cases and Materials, 3rd edition, 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.

5596.  Food Labeling and Regulatory Affairs (990) crn: 4160 Expectations of Online Students. You must use the Registration Form for Online Courses for this course.
6:30 pm - 9:30 pm Thursdays: May 30, June 6, 13, 20, 27, July 2 (Tuesday), 11, 18, 25, Aug 1, 8, 13 (Tuesday).  Meets 12 times plus final exam.  Make-up, if needed, Aug 15.  No class July 4.  Proctored exam:  Aug 1 (or last class class). Research products and presentations due July 18 and Aug 13 (or last class date).
Faculty:  Kirk Sooter
No required text.

line

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

How to Register

Is this your first registration in the QA/RA graduate program? 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.

RETURN TO
QA/RA HOMEPAGE

 
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