QA/RA Online Course Schedule – Fall 2012


Notes:
You must purchase a headset with a built-in microphone for all online courses, and you must test the headset for compatibility with the Adobe Connect and/or WebEx systems. If the course instructor feels a webcam is necessary, you are also required to purchase one. Having a webcam will enhance your class presentations.

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.

If you are taking a WebEx course, we will contact you after you register with instructions on how to use the Cisco WebEx system.

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.

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.

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

Fall 2012 - Semester begins September 4, 2012

 

JUST ADDED:
5571.  Post Marketing Safety Surveillance (990) crn: 21141
6:00 pm – 9:00 pm Wednesdays:  Sept 12, 19, Oct 3, 10, 17, 24, 31 (Halloween), Nov 7, 14, 28, Dec 5, 12.  Meets 12 times plus final exam.  No class Sept 26 or Nov 21. In-class exam:  Dec 12 (tentative).  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.

5401.  Fundamentals of Pharmacology and Pharmacokinetics (990) crn: 20852 Expectations of Online Students. You must use the Adobe/WebEx registration form for this class.
Special note:  this course will be offered through WebEx.
6:00 pm – 9:00 pm Tuesdays:  Sept 11, 18, 25, Oct 2, 9, 16, 23, 30, Nov 6, 13, 20, 27.  Meets 12 times plus final exam.  Make-ups, if needed, Dec 4 or 11.  Proctored exam:  Oct 23 (tentative).
Faculty:  Carol Cronenberger and Kevin Sweeney
No text required.  These texts are suggested for reference:  1) Applied Biopharmaceutics and Pharmacokinetics, Shargel, Yu, Wu-Pon (ISBN:  0071375503), and 2) Pharmacological Basis of Therapeutics, Good man and Gill, (ISBN: 0-070-135469-7).
Formerly Pharmaceutics 400.  Not open to students who have taken Pharmaceutics 400.

5459. Drug Development   (990)  crn: 17910 Expectations of Online Students. You must use the Adobe/WebEx registration form for this class.
6:00 pm – 9:00 pm Thursdays:  Sept 6, 20, 27, Oct 4, 11, 18, 25, Nov 1, 8, 15, 29,  Dec 6.  Meets 12 times plus final exam.  No class Sept 13 and Nov 22 (Thanksgiving).  Make-ups, if needed, Dec 13 or 20.  Proctored exam:  Oct 18 (tentative).
Faculty:  Dom Reigle
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.

5459. Drug Development   (991)  crn: 7404 Expectations of Online Students. You must use the Adobe/WebEx registration form for this class.
6:00 pm – 9:00 pm Tuesdays:  Sept 4, 11, 18, 25, Oct 2, 9, 16, 23, 30, Nov 6, 13, 20.  Meets 12 times plus final exam.  Make-ups, if needed, Nov 27 or Dec 4.   Proctored exam:  Oct 9 (tentative).  
Faculty:  Alan 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 Adobe/WebEx registration form for this class. CLOSED. Wait List Only.
Prerequisite:  Drug Development (Pharmaceutics 5459).
6:00 pm – 9:00 pm Thursdays:  Sept 6, 13, 20, 27, Oct 4, 11, 18, 25, Nov 1, 8, 15, 29.  Meets 12 times plus final exam.  No class Nov 22 (Thanksgiving).  Make-ups, if needed, Dec 6 or 13.  Proctored exam:  Oct 11 (tentative).
Faculty:  Cindy Cilberto
No required text.
Formerly Pharmaceutics 483.  Not open to students who have taken Pharmaceutics 483.

5477.  Good Manufacturing Practices (990) crn: 9357 Expectations of Online Students. You must use the Adobe/WebEx registration form for this class. CLOSED. WAIT LIST ONLY.
Special note: this course will be offered through WebEx and Adobe Connect.
7:00 pm – 10:00 pm Mondays: Sept 10, 17 (Rosh Hashanah), 24, Oct 1, 8 (Columbus Day), 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 (tentative).
Faculty: Karen Zimm
No required text.
Formerly Pharmaceutics 487. Not open to students who have taken Pharmaceutics 487.

5494.  Quality Audit (990) crn:  17912 Expectations of Online Students. You must use the Adobe/WebEx registration form for this class. CLOSED. WAIT LIST ONLY.
Prerequisite:  a good practices course (Pharmaceutics 5476, 5477, 5479, or 5536).
6:00 pm – 9:00 pm Tuesdays:  Sept 4, 11, 18, 25, Oct 2, 9, 16, 23, 30, Nov 6, 13, 20.   Meets 12 times plus final exam. Make-ups, if needed, Nov 27 or Dec 4.  Proctored exam:  Oct 16 (tentative).
Faculty:  Jeff Werrmann
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).
Formerly Pharmaceutics 494.  Not open to students who have taken Pharmaceutics 494.

5496.  Regulation of Medical Devices:  Compliance (990) crn: 20854 Expectations of Online Students. You must use the Adobe/Connect registration form for this class.
Note:  this course will be offered through WebEx and Adobe Connect.
6:00 pm – 9:00 pm Thursdays:  Sept 6, 13, 20, 27, Oct 4, 11, 18, 25, Nov 1, 8, 15, 29.  Meets 12 tines plus final exam.  Make-ups, if needed, Dec 6 or 13.  Proctored exam:  Oct 18 (tentative).  No class Nov 22 (Thanksgiving).
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: 20855 Expectations of Online Students. You must use the Adobe/WebEx registration form for this class.
7:00 pm – 10:00 pm Mondays:  Sept 10, 17 (Rosh Hashanah), 24, Oct 1, 8 (Columbus Day), 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 (tentative). 
Faculty:  Marcia Arentz
No required text.
Formerly Pharmaceutics 505.  Not open to students who have taken Pharmaceutics 505.

5536. Good Clinical Practices (990) crn: 9358 Expectations of Online Students. You must use the Adobe/WebEx registration form for this class.
6:00 pm – 9:00 pm Wednesdays:  Sept 5, 12, 19, 26 (Yom Kippur), Oct 3, 10, 17, 24, 31 (Halloween), Nov 7, 14, 28.  Meets 12 times plus final exam.  Make-ups, if needed, Dec 5 or 12.  No class Nov 21 (Thanksgiving eve). Proctored midterm: Oct 10 (tentative).
Faculty:  Debra 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.

5538.  Clinical Drug Safety and Pharmacovigilance (990) crn: 17920 Expectations of Online Students. You must use the Adobe/WebEx registration form for this class. CLOSED. WAIT LIST ONLY.
Suggested prerequisite:  Drug Development (Pharmaceutics 5459).
7:00 pm – 10:00 pm Thursdays:  Sept 6, 13, 20, 27, Oct 4, 11, 18, Nov 1, 8, 15, 29, Dec 6.  Meets 12 times plus final exam.  No class Oct 25 or Nov 22 (Thanksgiving).  Make-up, if needed, Dec 20.  Proctored exam: Dec 13 (tentative).
Faculty:  Janis 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.

5592.  Food and Drug Law I (990) crn:  7202 Expectations of Online Students. You must use the Adobe/WebEx registration form for this class.
7:00 pm – 10:00 pm Wednesdays:   Sept 5, 12, 19, 26 (Yom Kippur), Oct 3, 10, 17, 24, 31 (Halloween), Nov 7, 14, 28.  Meets 12 times plus final exam. No class Nov 21 (Thanksgiving eve). Make-ups, if needed, Dec 5 or 12.  Proctored midterm:  Oct 10 (tentative).
Faculty:  Gail 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.

5594.  Regulation of Dietary Supplements, Botanicals, and Nutraceuticals (990) crn: 20856 Expectations of Online students. You must use the Adobe/WebEx registration form for this class.
6:00 pm – 9:00 pm Mondays:  Sept 10, 17 (Rosh Hashanah), 24, Oct 8 (Columbus Day), 15, 22, 29, Nov 5, 12, 19, 26, Dec 3.  Meets 12 times plus final exam.  Make-ups, if needed, Dec 10 or 17.  No class Oct 1.  Proctored exam:  Oct 29 (tentative).
Faculty:  Alexa Smith
Required text:  A Global Perspective:  Regulation of Functional Food and Nutraceuticals, Clare M. Masler, 5th ed., (ISBN:  0-8138-1177-5.)
Formerly Pharmaceutics 594.  Not open to students who have taken Pharmaceutics 594.

5595.  Food Law (990)  crn: 20857 Expectations of Online Students. You must use the Adobe/WebEx Registration Form for this course.
6:00 pm – 9:00 pm Wednesdays:  Sept 5, 12, 19, 26 (Yom Kippur), Oct 3, 10, 17, 24, 31 (Halloween), Nov 7, 14, 28.  Meets 12 times plus final exam.  No class Nov 21 (Thanksgiving eve).  Make-ups, if needed, Dec 5 or 12.  Proctored exam:  Oct 17 (tentative).
Faculty:  Kirk Sooter
No required text.

5612.  Bioethics for Pharmaceutical Professionals (990) crn: 20858 Expectations of Online Students. You must use the Adobe/WebEx Registration Form for this course. CLOSED. Wait List Only.
6:00 pm – 9:00 pm Thursdays:  Sept 6, 13, 20, 27, Oct 4, 11, 18, 25, Nov 1, 8, 15, 29.  Meets 12 times plus final exam. Make-ups, if needed, Dec 6 or 13.  No class Nov 22 (Thanksgiving).  Proctored exam:  Oct 25 (tentative).
Faculty:  Elora Weringer
Required text:  Bioethics:  An Introduction to the History, Methods, and Practice, Jecker, 2nd ed, 2007, Jones & Bartlett Learning, (ISBN:  0763743143).
Formerly Pharmaceutics 610.  Not open to students who have taken Pharmaceutics 610.

5655.  Analytical Chemistry in Pharmaceutical Laboratories (990) crn: 20859 Expectations of Online Students. You must use the Adobe/WebEx registration form for this class.
Strong science background required.  Fax resume for approval to 256.468.8565.
6:00 pm – 9:00 pm  Tuesdays:  Sept 4, 11, 18, 25, Oct 2, 9, 16, 23, 30, Nov 6, 13, 20.  Meets 12 times plus final exam.  Make-ups, if needed, Nov 27 or Dec 4.  Proctored exam:  Oct 16 (tentative).
Faculty:  Kim HuynhBa and Frank Diana
Tentative required text:  Handbook of Stability Testing in Pharmaceutical Development:  Regulations, Methodologies, and Best Practices, Huynh-Ba (ed), Springer Sciences and Publishing, 2008, (ISBN:  978-0387856261).

8004.  Pharmaceutical Manufacturing II:  Solid Dosage Forms (990) crn: 20851 Expectations of Online Students. You must use the Adobe/WebEx Registration Form for this course. CLOSED. Wait List Only.
7:00 pm – 10:00 pm Wednesdays:  Sept 5, 12, 19, 26 (Yom Kippur), Oct 3, 10, 17, 24, Nov 7, 14, 28, Dec 5.  Meets 12 times plus final exam.  Make-ups, if needed, Dec 12 or 19.  No class Oct 31 (Halloween) or Nov 21 (Thanksgiving eve). Proctored midterm: Oct 3 (tentative).
Faculty:  Karen Zimm
Required text:  Aulton’s Pharmaceutics:  The Design and Manufacture of Medicines, 3rd ed, (ISBN:  978-0-443-10108-3).
Formerly Pharmaceutics 407.  Not open to students who have taken Pharmaceutics 407.

 

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Students MUST use the Adobe/WebEx 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: 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.

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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