Regulatory Affairs and Quality Assurance Graduate Program of Temple University School of Pharmacy

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RA and QA Online Course Schedule – Fall 2017

 

Click here for more information on how to register for an online course.

CLASSES are listed NUMERICALLY IN EAST COAST TIMES (please adjust accordingly for your time zone).

Schedule updated: September 26, 2017

NOTE:   Students are required to purchase webcams and headsets with microphones for Adobe Connect classes.  New students must watch the Adobe Connect tutorial and include the password mentioned at the end of the presentation on their registration form.

U.S. visa requirements stipulate that full-time international students must take on-campus courses.  A maximum of one online course is allowed per semester but only with special permission.

STARTS Wednesday, September 27:

5477.  Good Manufacturing Practices (991)  crn:  34740 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 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 Wednesdays:  Sept 27, Oct 4, 11, 18, 25, Nov 1, 8, 15, 29, Dec 6, 13. 20.  Meets 12 times plus final exam.  No class Nov 22. 
Proctored exam:  Nov 1 (Software Secure).
Faculty:  R. Alliegro
No required text.
Not open to students who have taken Pharmaceutics 487.

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5459.  Drug Development (990)  crn:  17910 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 12, 19, 26, Oct 3, 10, 17, 24, 31, Nov 7, 14, 21, 28, Dec 5.  Meets 12 times plus final exam.  Make-up, if needed, Dec 12.
Proctored exam:  Dec 5
Faculty:  S. Galle
Required text:  Drugs: From Discovery to Approval, Ng, 3rd ed, 2015 (ISBN-13:978-1118907276 or ISBN-10: 1118907272). 
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.
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 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:  Sept 11, 18, 25, Oct 2, 9 (Columbus Day), 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 16 (Software Secure).
Faculty:  A. Traettino  
Required text:  New Drug Development:  A Regulatory Overview, Mathieu, 8th ed, (ISBN: 1-882615-85-9).
Not open to students who have taken Pharmaceutics 459.

5459.  Drug Development (992) crn:  28608 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 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 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:  Sept 14, 21, 28, Oct 5, 12, 19, 26, Nov 2, 9, 16, 30, Dec 7.  No class Nov 23.  Meets 12 times plus final exam.  Make-ups, if needed,  Dec 14 or 21.
Proctored exam:  Oct 19 (Software Secure).
Faculty:  A. Traettino  
Required text:  New Drug Development:  A Regulatory Overview, Mathieu, 8th ed, (ISBN: 1-882615-85-9).
Not open to students who have taken Pharmaceutics 459.

WEEKEND COURSE
5459.  Drug Development (993) crn:   32262 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
10:00 am - 1:00 pm Sundays:  Sept 10, 17, 24, Oct 1, 8 (Columbus Day weekend), 15, 22, 29, Nov 5, 12, 19, Dec 3.  Meets 12 times plus final exam.  No class Nov 26.  Make-ups, if needed, Dec 10 or 17.
Proctored exam:  Oct 15.
Faculty:  D. Walsh
Required text:  Drugs From Discovery to Approval, Ng, 3rd ed, 2015 (ISBN-13:978-1118907276 or ISBN-10: 1118907272);  2) New Drug Development: A Regulatory Overview, Mathieu, 8th ed, (ISBN: 1-882615-85-9);  AND,
3) The Great Influenza: The Epic Story of the Deadliest Plague in History, Barry, Penguin Group, 2005, (ISBN: 13-9780143036494).
Not open to students who have taken Pharmaceutics 459.

5473.  Generic Drug Regulation (990)  crn:  20853 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Prerequisite:  Drug Development (5459) START DATE POSTPONED to SEPT 21.
6:00 pm - 9:00 pm Thursdays:  Sept 21, 28, Oct 5, 12, 19, 26, Nov 2, 9, 16, 30, Dec 7, 14.  Meets 12 times plus final exam.  No class Nov 23.  Make-ups, if needed, Dec 21.
Proctored exam:  Oct 26
Faculty:  C. Ciliberto
No required text.
Not open to students who have taken Pharmaceutics 483.

5474.  Process Validation (990)  crn:  28712 Expectations of Online Students. You must use the Registration Form for Online Courses for this class. CLOSED. WAIT LIST ONLY
Prerequisites: science background and basic familiarity with pharmaceutical manufacturing (such as completion of Pharm 5477, GMPs).
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 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:  Sept 11, 18, 25, Oct 2, 9 (Columbus Day), 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.
Faculty:  K. Barnthouse
Required texts:  1) How to Validate a Pharmaceutical Process, Steve Ostrove, 1st ed, Academic Press, 2016,  (ISBN:  9780128041482 or ebook:  9780128096536;  and 2) Process Validation in Manufacturing of Biopharmaceuticals, Rathore and Sofer, 3rd ed, (ISBN: 9781439850930).
Not open to students who have taken Pharmaceutics 484.

5476. Good Laboratory Practices (990) crn:  34776 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Note:  May be taken either as a traditional classroom course at Fort Washington or online through Adobe Connect.
6:00 pm - 9:00 pm Thursdays:  Sept 14, 21, 28, Oct 5, 12, 19, 26, Nov 2, 9, 16, 30, Dec 7.  Meets 12 times plus final exam.  No class Nov 23 (Thanksgiving).  Make-ups, if needed, Dec 14 or 21.
Proctored exam:  Oct 19
Faculty:  J. Goeke
No required text.
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.
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 or other location.  If you do not wish to participate in online proctoring, please do not sign up for this course.
6:30 pm - 9:30 pm  Mondays:  September 11, 18, 25, Oct 2, 16, 23, 30, Nov 6, 13, 20, 27, Dec 4, 11 (proctored final exam).   No class Oct 9. Meets 12 times plus final exam.  Make-up, if needed, Dec 18.
Proctored exam:  Dec 11 (Software Secure).
Faculty:  M. Noonan
No required text.
Not open to students who have taken Pharmaceutics 487.

5477.  Good Manufacturing Practices (991)  crn:  34740 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 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 Wednesdays:  Sept 27, Oct 4, 11, 18, 25, Nov 1, 8, 15, 29, Dec 6, 13.  Meets 12 times plus final exam.  No class Nov 22.  Make-up, if needed, Dec 20.
Proctored exam:  Oct 25 (Software Secure).
Faculty:  R. Alliegro
No required text.
Not open to students who have taken Pharmaceutics 487.

5493.  Sterilization Processes:  Manufacturing  (990)  crn:  Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Strong science background required.  Include resume with registration form.
6:00 pm - 9:30 pm Mondays:  Sept 11, 18, 25, Oct 2, 9 (Columbus Day), 16, 23, 30, Nov 6, 13.  Meets 10 times plus final exam.  Make-ups, if needed, Nov 20 or 27.
In-class, proctored exam:  Nov 6.
Faculty:  D. Casaburi
Required text:  Validation of Pharmaceutical Processes, Carleton and Agalloco, 3rd ed, (ISBN:  10:0-8493-7055-8).
Not open to students who have taken Pharmaceutics 493.

5494.  Quality Audit (990) crn:   25897 Expectations of Online Students. You must use the Registration Form for Online Courses for this class. CLOSED. WAIT LIST ONLY
Prerequisite:  a good practices (GxP) course: GLPs (5476) , GMP (5477), Advanced GMPs (5479), or GCPs (5536).
6:00 pm - 9:00 pm Thursdays:  Sept 14, 21, 28 (recording), Oct 5, 12 (recording), 19, 26, Nov 2, 9, 16, 30,  Dec 7.  Meets 12 times plus final exam.  No class Nov 23. Make-ups, if needed, Dec 14 or 21.
Proctored exam:  Oct 26.
Faculty:  K. Huynh-Ba
Required text:  The ASQ Auditing Handbook, 4th ed, J.P. Russell.  Available from ASQ Quality Audit Division: www.asq.org  (ISBN: 10-0873898478 only).  Do not purchase an ebook copy.  Also available on Amazon.com.
Not open to students who have taken Pharmaceutics 494.

5495.  IND/NDA Submissions (990) crn: 34741 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 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 or other location.  If you do not wish to participate in online proctoring, please do not sign up for this course.
Prerequisite: Drug Development (5459) or Food and Drug Law (5592).
6:00 pm – 9:00 pm Tuesdays:  Sept 12, 19, 26, Oct 3, 10, 17, 24, 31, Nov 7, 14, 21, 28.  Meets 12 times plus final exam.    Make-ups, if needed,  Dec 5 or 12.
Proctored exam:  Oct 24 (Software Secure).
Faculty:  A. Smith
Required text:  Drugs: From Discovery to Approval, Ng, 3rd ed, 2015 (ISBN-13:978-1118907276 or ISBN-10: 1118907272).
Not open to students who have taken Pharmaceutics 495.

5496.  Regulation of Medical Devices:  Compliance (990)  crn:  25899 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 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:  Sept 13, 20 (Rosh Hashanah), 27, Oct 4, 11, 18, 25, Nov 1, 8, 15, 29, Dec 6.  No class Nov 22. Meets 12 times plus final exam.  Make-ups, if needed, Dec 13 or 20. 
Proctored exam:  Oct 25  (Software Secure).
Faculty:  M.  Arentz
No required text.
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 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 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:  Sept 12, 19, 26, Oct 3, 10, 17, 24, 31, Nov 7, 14, 21, 28.  Meets 12 times plus final exam.  Make-ups, if needed, Dec 5 or 12.
Proctored exam:  Oct 24 (Software Secure)
Faculty:  M. Arentz
No required text.
Not open to students who have taken Pharmaceutics 505.

5508.  Good Pharmacovigilance Operations (990) crn: 25900 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Note:  May be taken either as a traditional classroom course at Fort Washington or online through Adobe Connect.
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 or other location.  If you do not wish to participate in online proctoring, please do not sign up for this course.
Prerequisite: Drug Development (5459).
6:00 pm - 9:00 pm Tuesdays:  Sept 12, 19, 26, Oct 3, 10, 17, 24, 31, Nov 7, 14, 21, 28.  Meets 12 times plus final exam. Make-up, if needed, Dec 5 or 12.
Proctored exam:  Oct 17 (Software Secure).
Faculty:  C. Wittrock
No required text.

5513.  Active Pharmaceutical Ingredients (APIs) (990)  crn:  34745 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 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 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 Mondays:  Sept 11, 18, 25, Oct 2, 9 (Columbus Day), 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 (Software Secure)
Faculty:  K. Zimm
No required text.

5514.  Regulatory eSubmissions (990) crn:  34746 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 or other location.  If you do not wish to participate in online proctoring, please do not sign up for this course.
Suggested prerequisites:  Drug Development (5459) and IND/NDA Submissions (5495).  Students who have not taken both of these courses should submit a resume for permission to register.
6:00 pm - 9:00 pm Wednesdays:  Sept 13, 20 (Rosh Hashanah), 27, Oct 4, 11, 18, 25, Nov 1, 8, 15, 29, Dec 6.  Meets 12 times plus final exam.  No class Nov 22.  Make-ups, if needed, Dec 13 or 20.
Proctored exam:  Oct 25 (Software Secure)
Faculty:  K. Davino
No required  text.

5515.  Biologics/Biosimilars:  A Regulatory Overview (990)  crn:  28574 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Prerequisite:  Drug Development (5459)
6:00 pm - 9:00 pm Tuesdays:  Sept 12, 19, 26, Oct 3, 10, 17, 24, 31, Nov 7, 14, 21, 28.  Meets 12 times plus final exam.  Make-ups, if needed, Dec 5 or 12.
Proctored exam:  Oct 31.
Faculty:  F. Diana
No required text.

5532.  Global Labeling Regulation:  Principles and Practices (990)  crn:  32030 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Suggested prerequisite:  Drug Development (5459)
6:00 - 9:00 pm Thursdays:  Sept 14, 21, 28, Oct 5, 12, 19, 26, Nov 2, 9, 16, 30, Dec 7.  Meets 12 times plus final exam.  No class Nov 23.  Make-ups, if needed, Dec 14 or 21.
Proctored exam:  Oct 19.
Faculty:  G. Nijveldt and B. Fanelli
No required text.

5536.  Good Clinical Practices (GCPs) (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 Mondays:  Sept 11, 18, 25, Oct 2, 9 (Columbus Day), 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. 
Faculty:  D. Weiss
Required text:  2015 CFR/ICH GCP Reference Guide. To order: ww.barnettinternational.com 
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.
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 or other location.  If you do not wish to participate in online proctoring, please do not sign up for this course.
Prerequisite:  Good Clinical Practices (5536) or permission of the RAQA Office (forward  resume with registration).
6:00 pm - 9:00 pm Tuesdays:  Sept 12, 19, 26, Oct 3, 10, 17, 24, 31, Nov 7, 14, 21, 28.  Meets 12 times plus final exam.
Make-ups, if needed, Dec 5 or 12.
Proctored exam:  Oct 24 (Software Secure).
Faculty:  J. Scavone
No required text.
Not open to students who have taken Pharmaceutics 537.

5538.  Clinical Drug Safety and Pharmacovigilance (990)  crn:  28576 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Note:  May be taken either as a traditional classroom course at Fort Washington or online through Adobe Connect.
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 or other location.  If you do not wish to participate in online proctoring, please do not sign up for this course.
Prerequisite:  Good Clinical Practices (5536).
6:00 pm - 9:00 pm Thursdays:  Sept 14, 21 (Rosh Hashanah), 28, Oct 5, 12, 19, 26, Nov 2, 9, 16, 30, Dec 7. Meets 12 times plus final exam.  No class Nov 23 (Thanksgiving). Make-ups, if needed, Dec 14 or 21.
In-class, proctored exam:  Oct 19 (Software Secure).
Faculty:  C. Wittrock
Required text: Pharmacovigilance Medical Writing:  A Good Practice Guide, Orleans-Lindsay, ISGN:  978-1-119-96726-2).
Not open to students who have taken Pharmaceutics 538 or 5571.

5545.  Post Approval Changes (990) crn:  32032 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 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 Wednesdays:  Sept 13, 20 (Rosh Hashanah), 27, Oct 4, 11, 25, Nov 1, 8, 15, 29, Dec 6.  Meets 12 times plus final exam.  Make-up, if needed, Dec 13 or 20.
Proctored exam:  Oct 25 (Software Secure)
Faculty:  K. Zimm
No required text.

5547.  Project Management for Clinical Trials (990)  crn: 34715 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Not open to students who have taken Project Management (5615 or 615).
6:00 pm - 9:00 pm Wednesdays:  Sept 13, 20 (Rosh Hashanah), 27, Oct 4, 11, 18, 25, Nov 1, 8, 15, 29, Dec 6.  Meets 12 times plus final exam.  No class Nov 22.  Make-ups, if needed, Dec 13 or 20.
Proctored exam:  Oct 18.
Faculty:  J. Sheldon
Recommended text:  Project Management for the Pharmaceutical Industry, June 2011, Revised Reprint. Available on Library website:  http://site.ebrary.com/lib/templeuniv/detail.action?docID=10466706).

5578Benefit-Risk Management and Safety Signaling of Healthcare Products (990)  crn:  32033 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 14, 21, 28, Oct 5, 12, 19, 26, Nov 2, 9, 16, 30, Dec 7, 14 (proctored final exam.).  Meets 12 times plus final exam.  No class Nov 23.  Make-up, if needed, Dec 21.
Proctored exam:  Dec 14.
Prerequisites:  Post Marketing Safety Surveillance (5571) or Clinical Drug  Safety and Pharmacovigilance (5538) or special permission of the RAQA Office (forward resume with registration form).
Faculty:  J. Clark
Recommended text: Council of International Organizations of Medical Sciences (CIOMS):  CIOMS IX Report: Practical Considerations for Development and Application of a Toolkit for Medicinal Product Risk Management, 2014.  Obtain from:  http://www.cioms.ch/index.php/publications/order-formv3

5579.  Regulatory and Legal Basis of Pharmacovigilance (990)  crn:   28579 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Note:  this course may be taken either as a traditional classroom course at Fort Washington or online through Adobe Connect.
Prerequisite: one Temple U Pharmacovigilance course (5508, 5538, 5571, 5573, OR  5578) OR a minimum of 2 -3 years of pharmacovigilance experience in the industry (include resume indicating experience to waive prerequisite).
6:00 pm - 9:00 pm Wednesdays:  Sept 13, 20 (Rosh Hashanah), 27, Oct 4, 11, 18, 25, Nov 1, 8, 15, 29, Dec 6, 13 (proctored final exam).   Meets 12 times plus final exam.  Make-up, if needed, Dec 20.
Proctored exam:   Dec 13
Faculty:  D. Wallace
Suggested text:  Mann's Pharmacovigilance, Ronald D. Mann, Elizabeth B. Andrews, 2014, John Wiley & Sons, 3rd ed.

5579.  Regulatory and Legal Basis of Pharmacovigilance (990)  crn:  28579 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Note:  this course may be taken either as a traditional classroom course at Fort Washington or online through Adobe Connect.
Prerequisite: one Temple U Pharmacovigilance course (5508, 5538, 5571, 5573, OR  5578) OR a minimum of 2 -3 years of pharmacovigilance experience in the industry (include resume indicating experience to waive prerequisite).
6:00 pm - 9:00 pm Wednesdays:  Sept 13, 20 (Rosh Hashanah), 27, Oct 4, 11, 18, 25, Nov 1, 8, 15, 29, Dec 6, 13 (proctored final exam).   Meets 12 times plus final exam.  Make-up, if needed, Dec 20.
Faculty:  D. Wallace
Suggested text:  Mann's Pharmacovigilance, Ronald D. Mann, Elizabeth B. Andrews, 2014, John Wiley & Sons, 3rd ed.

5591.  Global Regulatory Affairs (990) crn:  23442 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 or other location.  If you do not wish to participate in online proctoring, please do not sign up for this course.
Prerequisite:  Drug Development (5459) or Food and Drug Law (5592).
6:00 pm – 9:00 pm Mondays:  Sept 11, 18, 25, Oct 2, 9 (Columbus Day), 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 16 (Software Secure).
Faculty:  D. Larkins
No required text.
Not open to students who have completed Pharmaceutics 591.

5592.  Food and Drug Law (990) crn:  7202 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 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:  Sept 13, 20 (Rosh Hashanah), 27, Oct 4, 11, 18, 25, Nov 1, 8, 15, 29, Dec 6.  Meets 12 times plus final exam.  No class Nov 22.  Make-ups, if needed, Dec 13 or 20.
Proctored exam:    to be announced.        
Faculty:  G. Pilgrim
Required text:   Food and Drug Law: Cases and Materials, 4th edition, Hutt, et al, Foundation Press, (ISBN: 1609301757).  Make sure you purchase the 4th edition (and not earlier editions).
Recommended text:  Statutory Supplement, Hutt, West Academic Publishing, 2014, (ISBN 9781634591904).
Not open to students who have taken Pharmaceutics 592.

 5592.  Food and Drug Law (991) crn:  23754 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 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:  Sept 12, 19, 26, Oct 3, 10, 17, 24, 31, Nov 7, 14, 28, Dec 5.  Meets 12 times plus final exam.  No class Nov 21. Make-ups, if needed, Dec 12 or 19.
Proctored exam:  to be announced.
Faculty:  G. Pilgrim
Required text:   Food and Drug Law: Cases and Materials, 4th edition, Hutt, et al, Foundation Press, (ISBN: 1609301757).  Make sure you purchase the 4th edition (and not earlier editions).
Recommended text:  Statutory Supplement, Hutt, West Academic Publishing, 2014, (ISBN 9781634591904).
Not open to students who have completed Pharmaceutics 592.

5592.  Food and Drug Law (992) crn:  34749 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 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:  Sept 11, 18, 25, Oct 2, 9 (recording), 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 (Software Secure)
Faculty:  M. Dronitsky
Required text: Food and Drug Law: Cases and Materials, 4th edition, Hutt, et al, Foundation Press, (ISBN: 1609301757).  Make sure you purchase the 4th edition (and not earlier editions).
Not open to students who have completed Pharmaceutics 592.

5597.  Food Good Manufacturing Practices (990)  crn:  32037 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 or other location.  If you do not wish to participate in online proctoring, please do not sign up for this course.
6:30 pm - 9:30 pm Thursdays:  September 14, 21, 28, Oct 5, 12, 19, 26, Nov 2, 9, 16, 30, Dec 7, 14 (proctored final exam).   No class Nov 23. Meets 12 times plus final exam.  Make-up, if needed, Dec 21.
Proctored exam:  Dec 14 (Software Secure).
Faculty:  M. Noonan
No required text.

5611.  Regulation of Advertising and Promotions (990)  crn:  34751 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 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:  Sept 13, 20 (Rosh Hashanah), 27, Oct 4, 11, 18, 25, Nov 1, 8, 15, 29, Dec 6.  Meets 12 times plus final exam.  No class Nov 22.  Make-ups, if needed, Dec 13 or 20.
Proctored exam:  Oct 25 (Software Secure)
Faculty:  M. Dronitsky
Required text:  FDA Requirements for Prescription Drug Promotion, John Driscoll, RAPS, 2013, (ISBN:  978-0-9829329-7-0).
Not open to students who have taken Pharmaceutics 611.

5612.  Bioethics for Pharmaceutical Professionals (990)  crn:  31998 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
6:00 pm - 9:00 pm Mondays:  Sept 11, 18, 25, Oct 2, 9, (Columbus Day), 16, 23, 30, Nov 6, 13, 20, 27.  Meets 12 times plus final exam.  Make-ups, if needed, Dec 4 or 11. 
In-class, proctored exam:  Oct 23.
Faculty:  E. Weringer
Required text:  Bioethics: Introduction to the History, Methods and Practice,  Jecker, Jonsen, and Pearlman, (ISBN:  13: 9780763785529).
Not open to students who have taken Pharmaceutics 610.

Students MUST use the Registration Form for Online Courses.

How to Register for an Online Course

Is this your first registration with Temple? If so, you must include a RESIDENCY FORM

Is this your fourth class with the RA and QA program? If so, you must include a Non-Matriculated Graduate Student Waiver.

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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 School of Pharmacy
Regulatory Affairs and Quality Assurance (RA and QA) Graduate Program
425 Commerce Drive, Suite 175
Ft. Washington, PA 19034

Order texts on-line via: Temple University Ambler Bookstore
267-468-8460

Drop/Add Policy

To receive a complete refund for a course, you must notify the RA and QA 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
Regulatory Affairs and Quality Assurance Graduate Program

425 Commerce Drive, Suite 175
Fort Washington, PA  19034
Phone: 267.468.8560
E-Mail:
qara@temple.edu