QA/RA Online Course Schedule – Spring 2014 (updated 2/10/14)


Notes:
Spring registration is now complete. Our summer 2014 class schedule will be available sometime in late March.

You must purchase a headset with a built-in microphone and a webcam for all QA/RA online courses. You must test your headset and web cam for compatibility with our online course platform with Dave Brickett (dbrick@temple.edu). Both items will enhance your class presentations and participation in our online courses.

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. Starting in the spring semester, there will be 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).

Spring 2014 - Semester begins January 20, 2014

 

5537.  Clinical Trial Management (990)  crn:  20667 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Prerequisite:  Good Clinical Practices (Pharmaceutics 536).
6:00 pm - 9:00 pm Mondays:  Jan 27, Feb 3, 10, 17 (Presidents' Day), 24, Mar 3, 10, 17, 24, 31, Apr 7, 14, 21 (proctored, in-class exam).  Meets 13 times (includes final exam).  Make-up, if needed, Apr 28 or May 5.  Proctored, in-class exam:  Apr 21.
Faculty: J. Scavone

5459. Drug Development  (990) crn: 7447 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
6:00 pm – 9:00 pm Tuesdays:  Jan 28, Feb 4, 11, 18, 25, Mar 4, 11, 18, 25, Apr 1, 8, 15.  Meets 12 times plus final exam.  Make-up, if needed, Apr 22.  Proctored exam:  Mar 11.
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).
Not open to students who have taken Pharmaceutics 459.

5472.  Pharmaceutical Marketing (990) crn:  20665 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
6:00 pm – 9:00 pm Wednesdays:  Jan 29, Feb 12, 19, 26, Mar 5, 12, 19, 26, Apr 2, 9, 16, 23.  Meets 12 times plus final exam. Proctored exam:  Mar 19.
Faculty:  D. Hisey
Required texts: 1)  Pharmaceutical Marketing:  Principles, Environment and Practice, Smith (ISBN:  0789015838).
2) Pharmaceutical Marketing, Rollins and Perr, Johnes & Bartlett Learning, ISBN:  978-1-4496-9799-0).
Not open to students who have taken Pharmaceutics 482.

5477.  Good Manufacturing Practices (990)  crn:  3439 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 per exam 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:  Jan 23, 30, Feb 6, 13, 20, 27, Mar 6, 13, 20, 27, April 3, 10.  Meets 12 times plus final exam.  Make-ups, if needed, Apr 17 or 24. Proctored exam:  Feb 27. 
Faculty:  K. Zimm
No required text.
Not open to students who have taken Pharmaceutics 487.

5478.  High Purity Water Systems (990)  crn:  23313 Expectations of Online Students. You must use the Registration Form for Online Courses for this class. CLOSED. WAIT LIST ONLY.
To learn more about this course:  http://qara-apache.temple.edu/Collentro/BC5478.html
7:15 pm - 9:30 pm Mondays:  Jan 27, Feb 3, 10, 17 (Presidents' Day), 24, Mar 3, 10, 17, 24, 31, Apr 7, 14, 21 (proctored exam).  Meets 12 times plus final (proctored) exam.  Make-ups, if needed, Apr 28 or May 5.  Proctored exam:  Apr 21.
Faculty:  William Collentro
Reference text:  Pharmaceutical Water - System Design, Operation, and Validation, Collentro, 2nd ed, Informa Healthcare, 2011 (ISBN:  9781420077827). Available electronically. Instructor will provide directions for ordering.
Not open to students who have taken Pharmaceutics 488.

5494.  Quality Audit (990)  crn:  23272 Expectations of Online Students. You must use the Registration Form for Online Courses for this class. CLOSED. WAIT LIST ONLY. SEE ADDED SECTION ON TUESDAY NIGHT BELOW.
Prerequisite:  a good practices course (either Pharmaceutics 5476, 5477, 5479 or 5536).
6:15 pm - 9:30 pm Thursdays:  Jan 23, 30, Feb 6, 13, 20, 27, Mar 6, 13, 20, 27, Apr 3, 10, 17 (proctored exam).  Meets 12 times plus final exam.  Make-ups, if needed, Apr 24 or May 1. Proctored exam:  April 17
Faculty:  S. van Valkenberg
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 (991)  crn:  23433
Prerequisite:  a good practices course (either Pharmaceutics 5476, 5477, 5479 or 5536).
6:15 pm - 9:30 pm Tuesdays:  Jan 28, Feb 4, 11, 18, 25, Mar 4, 11, 18, 25, Apr 1, 8, 15, 22 (proctored exam).  Meets 12 times plus final exam.  Make-ups, if needed, Apr 29 or May 6. Proctored exam:  April 22
Faculty:  S. van Valkenberg
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: 20675 Expectations of Online Students. You must use the Registration Form for Online Courses for this class. CLOSED. WAIT LIST ONLY.
Special note:  this course will use Software Secure, an online proctoring service that costs $15.00 per exam 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 Tuesdays:  Jan 21, 28, Feb 4, 11, 18, 25, Mar 4, 11, 18, 25, Apr 1, 8.  Meets 12 times plus final exam.  Make-ups, if needed, Apr 15 or 22.  Proctored exam:  Mar 4.
Faculty:  A. Smith
Required text: New Drug Development: A Regulatory Overview, Mathieu, 8th ed, (ISBN: 1-882615-85-9).
Note:  there will be assigned readings from the Mathieu text.  Students may purchase the 7th or 8th edition but not earlier ones.
 Not open to students who have taken Pharmaceutics 495.

5496.  Regulation of Medical Devices:  Compliance (990) crn:  23273 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 per exam and enables students to take their 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 Mondays:  Jan 27, Feb 3, 10, 17 (Presidents' Day), 24, Mar 3, 10, 17, 24, 31, Apr 7, 14.  Meets 12 times plus final exam.  Make-ups if needed, Apr 21 or 28.  Proctored exam:  Mar 10.
Faculty:  M. Arentz
No required text.
Not open to students who have taken Pharmaceutics 496.

5498.  Computer Validation (990)  crn: 23275 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
6:00 pm - 9:00 pm Mondays:  Jan 27, Feb 3, 10, 17 (Presidents' Day), 24, Mar 3, 10, 17, 24, 31, Apr 7, 14.  Meets 12 times.  Make-ups, if needed, Apr 21 or 28.  Proctored exam:  Mar 10.
Faculty:  T. Preziosi
Required text:  to be announced
Not open to students who have completed Pharmaceutics 498.

5502.  Medical Device Regulation:  Submissions (990) crn: 20666 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 per exam 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 Thursdays:  Jan 23, 30, Feb 6, 13, 20,  27, Mar 6, 13, 20, 27, Apr 3, 10.  Meets 12 times plus final exam. Make-ups, if needed, Apr 17 or 24.  Proctored exam:  Mar 6.
Faculty:  M. Arentz
No required text.
Not open to students who have taken Pharmaceutics 500.

5513.  Active Pharmaceutical Ingredients (APIs) (990) crn: 20741 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Prerequisite:  Drug Development (Pharmaceutics 5459).
Special note:  this course will use Software Secure, an online proctoring service that costs $15.00 per exam 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 special permission (fax resume to 267.468.8565).
7:00 pm – 10:00 pm Wednesdays:  Jan 22, 29, Feb 5, 12, 19,  26, Mar 5, 12, 19, 26, Apr 2, 9.  Meets 12 times plus final exam.  Make-ups, if needed, Apr 16 or 23.  Proctored exam:  Feb 26.
Faculty:  K. Zimm
No required text.

5515.  Biologics/Biosimilars:  A Regulatory Overview (990) crn: 20655 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) and Food and Drug Law I (Pharmaceutics 5592).  Students should have a science background, including familiarity with undergraduate chemistry and biology. Fax resume to 267.468.8565.
6:00 pm – 9:00 pm Mondays:  Jan 27, Feb 3, 10, 17 (Presidents' Day), 24, Mar 3, 10, 17, 24, 31, Apr 7, 14.  Meets 12 times plus final exam.  Make-ups, if needed, Apr 21 or 28.  Proctored exam:  Mar 10.
Faculty:  Frank Diana
No required text.

5536.  Good Clinical Practices (990)  crn:  23276 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 Wednesdays:  Jan 22, 29 Feb 5, 12, 19, 26, Mar 5, 12, 19, 26, Apr 2, 9 (proctored, final exam), 16 (last lecture).  Meets 12 times plus final exam. Make-up, if needed, Apr 23 or 30.  Proctored exam:  Apr 9.
Faculty:  N. Smith
No required text.
Not open to students who have taken Pharmaceutics 536.

5537.  Clinical Trial Management (990)  crn:  20667 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Prerequisite:  Good Clinical Practices (Pharmaceutics 536.
6:00 pm - 9:00 pm Mondays:  Jan 27, Feb 3, 10, 17 (Presidents' Day), 24, Mar 3, 10, 17, 24, 31, Apr 7, 14, 21 (proctored, in-class exam).  Meets 13 times (includes final exam).  Make-up, if needed, Apr 28 or May 5.  Proctored, in-class exam:  Apr 21
Faculty: J. Scavone
No required text.

5547.  Project Management for Clinical Trials (990) crn:  20669 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Prerequisites:  Drug Development (Pharmaceutics 5459) and Clinical Trial Management (Pharmaceutics 537).
6:00 pm – 9:00 pm Thursdays:  Jan 23, 30, Feb 6, 13, 20, 27, Mar 6 (proctored exam), 13, 20, 27, Apr 3, 10, 17.  Meets 12 times plus final exam.  Make-ups, if needed, Apr 24 or May 1. Proctored exam:  Mar 6.
Faculty:  J. Sheldon
Required text:  Project Management for the Pharmaceutical Industry, June 2011, Revised Reprint, ISBN:  978-1-4094-1894-8.

5578.  Benefit Risk Management and Safety Signaling of Healthcare Products (990)  crn:  8723 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
6:00 pm – 9:00 pm Thursdays:  Jan 30, Feb 6, 13, 20, 27, Mar 6, 13, 20, 27, Apr 3, 10, 17, 24.  Meets 12 times plus final exam. Make-up, if needed, May 1. Proctored exam: April 24.
Faculty:  J. Clark
Required text:  A Framework for Pharmaceutical Risk Management, Fetterman, Nickel, Pines, Slatko.
Prerequisites:  Students should have completed TWO of the following courses or must receive permission from the QARA Office (fax resume to 267-468-8565): 1) Post Marketing Safety Surveillance (Pharmaceutics 5571) or Clinical Drug Safety and Pharmacovigilance (Pharmaceutics 5538); 2) Regulatory and Legal Basis of Pharmacovigilance (Pharmaceutics 5579); 3) Good Pharmacovigilance Operations (Pharmaceutics 5508); or 4) Pharmacoepidemiology (Pharmaceutics 5573).

5579.  Regulatory and Legal Basis of Pharmacovigilance (990) crn:  20670  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:  Jan 28, Feb 4, 11, 18, 25, Mar 4, 11, 18, 25, Apr 1, 8, 15, 22 (in-class, proctored exam).  Class meets 12 times plus final exam.  Make-up, if needed, Apr 29.  Proctored 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).

5591.  Global Regulatory Affairs (990) crn: 20671 Expectations of Online Students. You must use the Registration Form for Online Courses for this class. CLOSED. WAIT LIST ONLY.
Special note:  this course will use Software Secure, an online proctoring service that costs $15.00 per exam and enables students to take their 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 Wednesdays:  Jan 22, 29, Feb 5, 12, 19, 26, Mar 5, 12, 19, 26, Apr 2, 9.  Meets 12 times plus final exam.  Make-ups, if needed, Apr 16 or 23.  Proctored exam:  Feb 26.
Faculty:  D. Larkins
No required text.
Not open to students who have completed Pharmaceutics 591.

5592.  Food and Drug Law I (990) crn:  9424 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:  Jan 22, 29, Feb 5, 12, 19, 26, Mar 5, 12, 19, 26, Apr 2, 9.  Meets 12 times plus final exam.  Make-ups, if needed, Apr 16 or 23.  Proctored exam:  Feb 19 (tentative).
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.
Not open to students who have taken Pharmaceutics 592.

5595. Food Law (990)  crn:  23277 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
6:30 pm - 9:30 pm Mondays:  Feb 3, 10, 17, 24, Mar 3, 10, 17, 24, 31, Apr 7, 14, 21, 28(proctored final exam).  Meets 12 times plus final exam.  Makeup, if needed, May 5.  Proctored exam:  Apr 28.
Faculty:  K. Sooter
Required text:  to be announced

5601.  Industry Interactions with FDA and Health Authorities (990)  crn:  8726 Expectations of Online Students. You must use the Registration Form for Online Courses for this class. CLOSED. WAIT LIST ONLY.
Special note: this course will use Software Secure, an online proctoring service that costs $15.00 per exam 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 Mondays:  Jan 27, Feb 3, 10, 17 (Presidents’ Day), 24, Mar 3, 10, 17, 24, 31, Apr 7, 14.  Meets 12 times plus final exam.  Make-ups, if needed, Apr 21 or 28.  Proctored exam:  Mar 3.
Faculty:  A. Traettino
No required text.
Not open to students who have completed Pharmaceutics 601.

5605.  Advanced Topics in Food and Drug Law (990) crn: 23279 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Prerequisite:  Food and Drug Law I (Pharmaceutics 5592) or permission of instructor.
6:00 pm - 9:00 pm Tuesdays:  Jan 21, 28, Feb 4, 11, 18, 25, Mar 4, 11, 18, 25, Apr 1, 8. Meets 12 times plus final exam.  Make-ups, if needed, Apr 15 or 22.  Proctored exam:  Feb 18 (tentative).
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.
Not open to students who have completed Pharmaceutics 605.

5655.  Analytical Chemistry in the Pharmaceutical Laboratory (990)  crn:  23278 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Prerequisite:  strong science background, consisting 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.
6:00 pm - 9:00 pm Tuesdays:  Jan 28, Feb 4, 11, 18, 25, Mar 4, 11, 18, 25, Apr 1, 8, 15.  Meets 12 times plus final exam.  Make-up, if needed, Apr 22.  Proctored exam: Mar 11.
Faculty:  F. Diana and K. Huynh-Ba
Required text:  Handbook of Stability Testing in Pharmaceutical Development:  Regulations, Methodologies, and Best Practices, (ISBN: 97809387856261), Kim Huynh-Ba (ed), Springer Sciences and Publishing, 2008.

8005.  Pharmaceutical Biotechnology (990) crn:  20673 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Prerequisite:  strong science background, consisting 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.
6:00 pm – 9:00 pm Thursdays:  Jan 23, 30, Feb 6, 13, 20, 27 (proctored exam), Mar 6, 13, 20, 27, Apr 3, 10, 17 (proctored exam).  Meets 12 times plus proctored final exam.  Make-ups if needed, Apr 24 or May 1.  Proctored exams:  Feb 27 and Apr 17.
Faculty:  T. Parry
Required text:  Pharmaceutical Biotechnology:  Fundamentals and Applications, Crommelin, Sindelar & Meibohm, eds, 3rd ed, Informa Healthcare 2007 (ISBN-10:  1420044370, ISBN-13 978-1420044379). Paperback recommended.
Suggested text: Biopharmaceuticals:  Biochemistry and Biotechnology, Walsh, G., 2nd ed, Wiley, West Sussex, England, 2003, $76.50, (ISBN 0-470-84327-6). Students should also have access to textbooks in biochemistry and/or molecular biology from previous courses.
Not open to students who have taken Pharmaceutics 475.

line

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: 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