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

spilling capsule

RA and QA Online Courses – Summer 2018 (updated May 21, 2018)

Summer 2018 is starting. Weeknight classes begin May 21. Weekend classes begin May 19. Forward your registration form and supporting documents to hold your spot in a class.

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).

Students are required to purchase headsets with microphones to participate in Adobe Connect online classes. They must also have a webcam on their laptop/computer. 

Due to U.S. visa requirements, full-time international students are expected to take all courses in an on-campus format. One online course may be pursued per semester, but only with special permission of the RAQA Office.

Please review all class dates carefully. Students are expected to take exams on the stated dates and to reserve any make-up dates. In observance of the July 4th holiday during the week of July 2-5, many (but not all) online courses will post recordings, which students may watch at their convenience before the next class meeting. Courses scheduled on Monays will also post recordings on Memorial Day (May 28th).

Software Secure is an online proctoring service used for exams. The service costs $15.00 per exam and enables students to take exams at home or other locations. Students are responsible for paying the $15.00 fee to Software Secure via credit card at the start of an exam. The fee is also charged when students take exams using Software Secure in any Temple U computer lab. If a course uses Software Secure, all students must use that service. 

5458.  The Global Biopharmaceutical Industry (990) crn: 8633 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Note:  this course may be completed either on-campus at Fort Washington or online through Adobe Connect.  Due to visa requirements, full-time international students must take this course in an on-campus format.
Prerequisite:  Drug Development (5459)
6:00 pm – 9:00 pm Thursdays:  May 24, 31, June 7, 14, 21, 28, July 5 (recording), 12, 19, 26, Aug 2, 9. Meets 12 times plus final exam.  Make-ups, if needed, Aug 16 or 23.
In-class, proctored exam:  July 12.
Faculty:  B. Berger
Required textThe Generic Challenge – Understanding Patents, FDA and Pharmaceutical Life-Cycle Management, Martine Voet, 4th edition.

5459.  Drug Development (990) crn:  2539 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
This course will use Software Secure online proctoring. Students are responsible for paying a $15.00 fee directly to Software Secure via credit card at the start of the proctored exam. 
6:00 pm – 9:00 pm Mondays:  May 21, 28 (recording), June 4, 11, 18, 25, July 2 (recording), 9, 16, 23, 30, Aug 6.  Meets 12 times plus final exam.  Make-ups, if needed, Aug 13 or 20.
Proctored exam:  June 25 (Software Secure)
Faculty:  A. Traettino  
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: 6040 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
6:00 pm - 9:00 pm Tuesdays:  May 22, 29, June 5, 12, 19, 26, July 3 (recording), 10, 17, 24, 31, Aug 7, 14 (proctored final exam).  Meets 12 times plus final exam.
Make-up, if needed, Aug 21 or 28.
Proctored exam:  Aug 14.
Faculty:  S. Galle
Required text:  Drugs: From Discovery to Approval, Ng, 3rd edition, 2015 (ISBN-13:978-1118907276 or ISBN-10: 1118907272).
Not open to students who have taken Pharmaceutics 459.

WEEKEND COURSE
5459.  Drug Development (992) crn: 7675 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
10:00 am - 1:00 pm Saturdays:  May 19, 26 (recording), June 2, 9, 16, 23, 30, July 7, 14, 21, 28, Aug 4. Meets 12 times plus final exam.   Make-ups, if needed, Aug 11 or 18.
Proctored exam:  July 7.
Faculty:  D. Walsh
Three required texts: 
1) 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 edition, (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 (ANDAs) (990) crn: 8584 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 Thursdays:  May 24, 31, June 7, 14, 21, 28, July 5 (recording), 12, 19, 26, Aug 2, 9. Meets 12 times plus final exam.  Make-ups, if needed, Aug 16 or 23.
Proctored exam:  June 28.
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. CLOSED. WAIT LIST ONLY.
This course will use Software Secure online proctoring. Students are responsible for paying a $15.00 fee directly to Software Secure via credit card at the start of the proctored exam. 
6:30 pm - 9:30 pm Thursdays:  May 24, 31, June 7, 14, 21, 28, July 5 (recording), 12, 19, 26, Aug 2, 9, 16 (proctored final exam). Meets 12 times plus final exam.  Make-ups, if needed, Aug 23 or 30
Proctored exam:  Aug 16 (Software Secure).
Faculty:  M. Noonan
No required text.
Not open to students who have taken Pharmaceutics 487.

5479.  Advanced Good Manufacturing Practices – Defining “c” (990) crn: 7676 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
This course will use Software Secure online proctoring. Students are responsible for paying a $15.00 fee directly to Software Secure via credit card at the start of the proctored exam. 
Prerequisite:  Successful completion of Pharmaceutics 5477 or permission of the instructor.
7:00 pm – 10:00 pm Mondays:  May 21, 28 (recording), June 4, 11, 18, 25, July 9, 16, 23, 30, Aug 6, 13.  Meets 12 times plus final exam.  No class July 2.  Make-ups, if needed, Aug 20 or 27.
Proctored exam:  July 9 (Software Secure).
Faculty:  K. Zimm
No required text.
Not open to students who have taken Pharmaceutics 479.

5493.  Sterilization Processes: Manufacturing (990) crn:  8581 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Note:  this course may be completed either on-campus at Fort Washington or online through Adobe Connect.  Due to visa requirements, full-time international students must take this course in an on-campus format.
This course will use Software Secure online proctoring. Students are responsible for paying a $15.00 fee directly to Software Secure via credit card at the start of the proctored exam. 
6:00 pm – 9:00 pm Mondays:  May 21, June 4, 11, 18, 25, July 2, 9, 16, 23, 30, Aug 6, 13.  No class May 28 (Memorial Day).   Meets 12 times plus final exam.  Make-ups, if needed, Aug 20 or 27.
Proctored exam:  Aug 6 (Software Secure).
Faculty:  D. Casaburi
Required text: Validation of Pharmaceutical Processes, Agalloco and Carleton, 3rd edition (ISBN-13:9780849370557 or ISBN-10: 0849370558).
Not open to students who have taken Pharmaceutics 493.

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 (GxP) course: GLPs (5476) , GMP (5477), Advanced GMPs (5479), or GCPs (5536).
6:30 pm - 9:45 pm Mondays:  May 21, 28 (recording), Jun 4, 11, 18, 25, July 2, 9, 16, 23, 30, Aug 6, 13 (proctored final exam). Meets 12 times plus final exam.   Make-ups, if needed, Aug 20 or 27.
Proctored exam:  Aug 13.
Faculty:  S. Van Valkenburg
Required text:  The ASQ Auditing Handbook, 4th edition, 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.

5494. Quality Audit (991) crn: 8632 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Prerequisite:  a good practices (GxP) course: GLPs (5476) , GMP (5477), Advanced GMPs (5479), or GCPs (5536).
6:00 pm – 9:00 pm Wednesdays:  May 23, 30, June 6, 13, 20, 27, July 4 (recording), 11, 18, 25, Aug 1, 8, 15.  Meets 12 times plus final exam.  No live class July 4 (recording provided).  Make-ups, if needed, Aug 15 or 22.
Proctored exam: July 11
Faculty: K. Huyhn-ba
Required text:  The ASQ Auditing Handbook, 4th edition, 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: 2531 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
This course will use Software Secure online proctoring. Students are responsible for paying a $15.00 fee directly to Software Secure via credit card at the start of the proctored exam. 
Prerequisite: Drug Development (5459) or Food and Drug Law (5592).
6:00 pm – 9:00 pm Thursdays:   May 24, 31, June 7, 14, 21, 28, July 5 (recording), 12, 19, 26, Aug 2, 9. Meets 12 times plus final exam.  Make-ups, if needed, Aug 16 or 23.
Proctored exam:  June 28 (Software Secure).
Faculty:  A. Traettino  
Required text:  Drugs: From Discovery to Approval, Ng, 3rd edition, 2015 (ISBN-13:978-1118907276 or ISBN-10: 1118907272).
Not open to students who have taken Pharmaceutics 495.

5495.  IND/NDA Submissions (991) crn:  8616 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
This course will use Software Secure online proctoring. Students are responsible for paying a $15.00 fee directly to Software Secure via credit card at the start of the proctored exam. 
Prerequisite: Drug Development (5459) or Food and Drug Law (5592).
6:00 pm – 9:00 pm Tuesdays:  May 22, 29, June 5, 12, 19, 26, July 3 (recording), 10, 17, 24, 31, Aug 7. Meets 12 times plus final exam.    Make-ups, if needed, Aug 14 or 21.
Proctored exam:  June 26 (Software Secure).
Faculty:  A. Smith
Required text:  Drugs: From Discovery to Approval, Ng, 3rd edition, 2015 (ISBN-13:978-1118907276 or ISBN-10: 1118907272) OR New Drug Development: A Regulatory Overview, Mathieu, 8th edition, (ISBN: 1-882615-85-9).
Not open to students who have taken Pharmaceutics 495.

5496.  Regulation of Medical Devices:  Compliance (990)  crn: 5869 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
This course will use Software Secure online proctoring. Students are responsible for paying a $15.00 fee directly to Software Secure via credit card at the start of the proctored exam. 
6:00 pm – 9:00 pm Tuesdays:  May 22, 29, Jun 5, 12, 19, 26, July 10, 17, 24, 31, Aug 7, 14.  Meets 12 times  plus final exam.  No class July 3. Make-ups, if needed, Aug 21 or 28. 
Proctored exam:  July 10 (Software Secure).
Faculty:  M. Arentz
No required text.
Not open to students who have taken Pharmaceutics 496.

5502.  Regulation of Medical Devices:  Submissions (990) crn:  8589 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
This course will use Software Secure online proctoring. Students are responsible for paying a $15.00 fee directly to Software Secure via credit card at the start of the proctored exam. 
6:00 pm – 9:00 pm Wednesdays: May 23, 30, Jun 6, 13, 20, 27, July 11, 18, 25, Aug 1, 8, 15.  Meets 12 times plus final exam. No class July 4.  Make-ups, if needed, Aug 22 or 29. 
Proctored exam:  July 11 (Software Secure).
Faculty:  M. Arentz
No required text.
Not open to students who have taken Pharmaceutics 500.

5508.  Good Pharmacovigilance Operations (990) crn:  5870 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Note:  this course may be completed either on-campus at Fort Washington or online through Adobe Connect.  Due to visa requirements, full-time international students must take this course in an on-campus format.
Note: This course will use Software Secure online proctoring.  Students are responsible for paying a $15.00 fee directly to Software Secure via credit card at the start of the proctored exam.
Prerequisite: Drug Development (5459).
6:00 pm - 9:00 pm Thursdays:  May 24, 31, June 7, 14 (recording), 21, 28, July 5 (recording), 12, 19, 26, Aug 2 (recording), 9. Meets 12 times plus final exam.  Make-ups, if needed, Aug 16 or 23.
Proctored exam:  June 28 (Software Secure)  
Faculty:  C. Wittrock
No required text.

5508.  Good Pharmacovigilance Operations (991) crn: 8785 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Note:  this course may be completed either on-campus at Fort Washington or online through Adobe Connect.  Due to visa requirements, full-time international students must take this course in an on-campus format.
Note: This course will use Software Secure online proctoring.  Students are responsible for paying a $15.00 fee directly to Software Secure via credit card at the start of the proctored exam.
Prerequisite: Drug Development (5459).
6:00 pm - 9:00 pm Tuesdays:  May 22, 29, June 5, 12 (recording), 19, 26, July 3 (recording), 10, 17, 24, 31 (recording), Aug 7. Meets 12 times plus final exam.  Make-ups, if needed, Aug 14 or 21.
Proctored exam:  June 26 (Software Secure)  
Faculty:  C. Wittrock
No required text.

5515.  Biologics/Biosimilars: A Regulatory Overview (990)  crn:  8579 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Prerequisites:  Drug Development (5459).  Science background required.
6:00 pm – 9:00 pm Mondays:  May 21, 28 (recording), June 4, 11, 18, 25, July 2, 9, 16, 23, 30, Aug 6.  Meets 12 times plus final exam.  Make-ups, if needed, Aug 13 or 20.
Proctored exam:  July 9.
Faculty:  F. Diana
No required text.

5516.  Cleaning Validation (990) crn: 3422 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Prerequisite:  Drug Development (5459) or Food and Drug Law (5592).
6:00 pm – 9:00 pm Tuesdays:  May 22, 29, June 5, 12, 19, 26, July 3 (recording), 10, 17, 24, 31, Aug 7, 14 (proctored final exam).  Meets 12 times plus final exam.  Make-ups, if needed, Aug 21 or 28.
Proctored exam:  Aug 14.
Faculty:  R. Forsyth
No required text.

5533.  Requirements for Product Labeling and Advertising (990) crn:  5871 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
This course will use Software Secure online proctoring. Students are responsible for paying a $15.00 fee directly to Software Secure via credit card at the start of the proctored exam. 
Prerequisite:  Food and Drug Law (5592) or permission of instructor.
6:00 pm - 9:00 pm Thursdays: May 24, 31, June 7, 14, 21, 28, July 5 (recording), 12, 19, 26, Aug 2, 9, 16.  Meets 12 times plus final exam.  Make-ups, if needed, Aug 23 or 30. 
Proctored exam:  Aug 16 (Software Secure).
Faculty:  J. Bammert
No required text.
Not open to students who have taken Pharmaceutics 533.

5536.  Good Clinical Practices (990) crn:  3423 Expectations of Online Students. You must use the Registration Form for Online Courses for this class. CLOSED. WAIT LIST ONLY.
Note:  this course may be completed either on-campus at Fort Washington or online through Adobe Connect.  Due to visa requirements, full-time international students must take this course in an on-campus format.
Note: This course will use Software Secure online proctoring.  Students are responsible for paying a $15.00 fee directly to Software Secure via credit card at the start of the proctored exam.
6:00 pm – 9:00 pm Tuesdays:  May 22, 29, June 5, 12, 19, 26, July 3 (recording), 10, 17, 24, 31, Aug 7.  Meets 12 times plus final exam.  Make-ups, if needed, Aug 14 and 21.
Proctored exam:  June 19 (Software Secure)
Faculty: J. Scavone
No required text.
Not open to students who have taken Pharmaceutics 536.

5537.  Clinical Trial Management (990) crn: 5872 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Prerequisite:  Good Clinical Practices (5536) or permission of RAQA Office.
This course will use Software Secure online proctoring. Students are responsible for paying a $15.00 fee directly to Software Secure via credit card at the start of the proctored exam. 
6:00 pm – 9:00 pm Wednesdays:  May 23, 30, June 6, 13, 20, 27, July 4 (recording), 11, 18, 25, Aug 1, 8.  Meets 12 times plus final exam.  Make-ups, if needed, Aug 15 or 22.
Proctored exam:  July 11 (Software Secure).
Faculty:  J. Scavone
No required test.
Not open to students who have completed Pharmaceutics 537.

5545.  Post Approval Changes (PAC) (990) crn: 7677 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
This course will use Software Secure online proctoring. Students are responsible for paying a $15.00 fee directly to Software Secure via credit card at the start of the proctored exam. 
7:00 pm – 10:00 pm Wednesdays:  May 23, 30, June 6, 13, 20, 27, July 11, 18, 25, Aug 1, 8, 15.  Meets 12 times plus final exam.  No class July 4.  Make-ups, if needed, Aug 22 or 29.
Proctored exam:  July 11 (Software Secure).
Faculty:  K. Zimm
No required text.

5591.  Global Regulatory Affairs (990) crn: 1733  Expectations of Online Students. You must use the Registration Form for Online Courses for this class.  CLOSED. WAIT LIST ONLY.
This course will use Software Secure online proctoring. Students are responsible for paying a $15.00 fee directly to Software Secure via credit card at the start of the proctored exam. 
Prerequisite:  Drug Development (5459) or Food and Drug Law (5592).
6:00 pm – 9:00 pm Tuesdays:  May 22, 29, June 5, 12, 19, 26, July 3 (recording), 10, 17, 24, 31, Aug 7. Meets 12 times plus final exam. Make-ups, if needed, Aug 14 or 21.
Proctored exam:  June 26 (Software Secure)
Faculty:  D. Larkins
No required text.
Not open to students who have completed Pharmaceutics 591.

5592.  Food and Drug Law (990) crn: 1734 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
This course will use Software Secure online proctoring. Students are responsible for paying a $15.00 fee directly to Software Secure via credit card at the start of the proctored exam. 
6:00 pm – 9:00 pm Wednesdays:  May 23, 30, June 6, 13, 20, 27, July 4 (recording), 11, 18, 25, Aug 1, 8.  Meets 12 times plus final exam. Make-ups, if needed, Aug 15 or 22.
Proctored exam:  July 11 (Software Secure)          
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: 5886 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
This course will use Software Secure online proctoring. Students are responsible for paying a $15.00 fee directly to Software Secure via credit card at the start of the proctored exam. 
6:00 pm - 9:00 pm Tuesdays:  May 22, 29, June 5, 12, 19, 26, July 3 (recording), 10, 17, 24, 31, Aug 7. Meets 12 times plus final exam.  Make-ups, if needed, Aug 14 or 21.
Proctored exam:  July 10 (Software Secure).
Faculty:  G. Pilgirm
Required text: Food and Drug Law: Cases and Materials, 4th edition, Hutt, et al, Foundation Press, (ISBN:  1609301757).  Make sure to purchase the 4th edition (and not earlier editions).
Recommended text:  Statutory Supplement, Hutt, West Academic Publishing, (ISBN: 9781634591904).  Note:  a 2012 edition or later of this text is acceptable.
Not open to students who have taken Pharmaceutics 592.

5595.  Food Law (990)  crn: 8583 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
This course will use Software Secure online proctoring. Students are responsible for paying a $15.00 fee directly to Software Secure via credit card at the start of the proctored exam. 
6:30 pm – 9:30 pm Wednesdays:  May 23, 30, June 6, 13, 20, 27, July 4 (recording), 11, 18, 25, Aug 1, 8, 15 (proctored final exam).  Meets 12 times plus final exam.  Make-ups, if needed, Aug 22 or 29.
Proctored exam:  Aug 15 (Software Secure).
Faculty:  M. Noonan
No required text.

Students MUST use the Registration Form for Online Courses.

How to Register for an Online Course

Is this your first RAQA 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.

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 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.

RA and QA Homepage - General Information (Applying, Courses, Certificates)

Billing Procedures | Code Of Conduct | FAQs | Tuition

Certificates | Graduation

Return To RAQA Homepage

 
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