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

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Summer 2018 Schedule for the Regulatory Affairs and Quality Assurance Graduate Program (updated July 8, 2018)

Entire Schedule (On-Campus and Online Courses listed numerically by Course Number)


Please check class dates carefully. Students who cannot make the scheduled exam date will be charged a $20.00 fee for an initial makeup exam. The second time the fee increases to $30. Subsequently, the fee increases to $50.00 per exam. For more on this policy, click here.

ON-CAMPUS COURSES STARTING IN JULY - Still time to register!

ONLINE COURSE Starting July 12

5601.  Industry Interactions with FDA and Health Authorities (990) crn: 7880 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.
Special note:  this intensive class consists of 7 live online meetings and 5 recorded lectures.  Students must be willing to watch recordings between class meetings.
Live meetings: 6:00 pm - 9:00 pm Thursdays - July 12, 19, 26, Aug 2, 9, 16, 23.
Proctored final exam: Aug 23 (using Software Secure).
Make-ups, if needed, Aug 30.
Students are responsible for watching recorded lectures before the next class meeting: 
Recording #1: Watch before July 19
Recording #2: Watch before July 26
Recording #3: Watch before Aug 2
Recording #4: Watch before Aug 9
Recording #5: Watch before Aug 16
Faculty: A. Traettino
No required text.
Not open to students who have completed Pharmaceutics 601.

ON-CAMPUS COURSE Starting July 14

5579.  Legal and Regulatory Basis of Pharmacovigilance (111) crn:  5946
Hands-on experience with Argus Oracle will be included.
Suggested Prerequisite: One Pharmacovigilance course:  Either (5571) or  (5538) or (5508) or (5578). 
Meets 3 weekends (Saturday and Sunday):
9:30 am – 5:00 pm Sat (1/2 hour lunch): July 14, 28 & Aug 4.
9:30 am – 3:00 pm Sun (1/2 hour lunch): July 15, 29 & Aug 5.
In-class, proctored exam: Aug 11 (Saturday)
Make-up date, if needed: Sunday, Aug 12.
Faculty:  S. Thapar
No required text.

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5458.  The Global Biopharmaceutical Industry (111) crn: 7685
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.

5458.  The Global Biopharmaceutical Industry (990) crn:  8633 There is an online section of The Global Biopharmaceutical Industry on Thursday nights. See the Online Course Schedule for details. Use the Registration Form for Online Courses for this section.

5459. Drug Development (111) crn:  8578
6:00 pm - 9:30 pm Thursdays:  May 31, June 7, 14, 21, 28, July 5, 12, 19, 26, Aug 2. Meets 10 times plus final exam.  Make-ups, if needed, Aug 9 or 16.
In-class, proctored exam:  June 28.
Faculty:  P. Sax
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  There is an online section of Drug Development on Mondays. See the Online Course Schedule for details. Use the Registration Form for Online Courses for this section.

5459.  Drug Development (992) crn: 7675  There is an online section of Drug Development on Tuesdays. See the Online Course Schedule for details. Use the Registration Form for Online Courses for this section.

WEEKEND COURSE
5459.  Drug Development (992) crn: 7675  There is an online section of Drug Development on Saturday mornings. See the Online Course Schedule for details. Use the Registration Form for Online Courses for this section.

5473.  Generic Drug Regulation (ANDAs) (990) crn: 8584  There is an online section of Generic Drug Regulation on Thursday nights. See the Online Course Schedule for details. Use the Registration Form for Online Courses for this section.

5477. Good Manufacturing Practices (111) crn:  884
9:00 am - 3:30 pm Sundays (1/2 hour lunch):  May 20, June 3, 10, 24, July 1 (field trip to Almac in Souderton, PA), 15.   Meets 6 times plus final exam including mandatory field trip to Almac (July 1).  Make-up, if needed, July 22.
In-class, proctored exam:  June 24.
Faculty:  T. Ely
No required text.
Not open to students who have completed Pharmaceutics 487.

5477.  Good Manufacturing Practices (990) crn: 4136  There is an online section of Good Manufacturing Practices on Thursday nights. See the Online Course Schedule for details. Use the Registration Form for Online Courses for this section. CLOSED. WAIT LIST ONLY.

5479.  Advanced Good Manufacturing Practices – Defining “c” (990) crn: 7676  There is an online section of Advanced Good Manufacturing Practices – Defining “c” on Monday nights. See the Online Course Schedule for details. Use the Registration Form for Online Courses for this section.

5493.  Sterilization Processes: Manufacturing (111) crn: 8580 
Prerequisite:  strong science background.  This is an elective in the Pharmaceutics program.
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.

5493.  Sterilization Processes: Manufacturing (990) crn:  8581 There is an online section of Sterilization Processes:  Manufacturing on Monday nights. See the Online Course Schedule for details. Use the Registration Form for Online Courses for this section.

5494. Quality Audit (991) crn: 8632  There is an online section of Quality Audit on Wednesday nights. See the Online Course Schedule for details. Use the Registration Form for Online Courses for this section.

5494.  Quality Audit (990) crn: 4137  There is an online section of Quality Audit on Monday nights. See the Online Course Schedule for details. Use the Registration Form for Online Courses for this section.

5495.  IND/NDA Submissions (111) crn: 7670
Prerequisite: Drug Development (5459) or Food and Drug Law (5592).
8:30 am – 3:00 pm Saturdays (1/2 hour lunch):  May 19, June 2, 9, 23, July 14, 21.  Meets 6 times plus final exam.  No class June 30.  Make-up, if needed, July 28.
In-class, proctored exam:  June 23.
Faculty:  P. Smith
Required text:  New Drug Development:  A Regulatory Overview, Mathieu, 8th edition, (ISGN: 1-882615-85-9).
Not open to students who have completed Pharmaceutics 495.

5495.  IND/NDA Submissions (991) crn:  8616  There is an online section of IND/NDA Submissions on Tuesday nights. See the Online Course Schedule for details. Use the Registration Form for Online Courses for this section.

5495.  IND/NDA Submissions (990) crn: 2531  There is an online section of IND/NDA Submissions on Thursday nights. See the Online Course Schedule for details. Use the Registration Form for Online Courses for this section.

5496.  Regulation of Medical Devices:  Compliance (990)  crn: 5869  There is an online section of Regulation of Medical Devices:  Compliance on Wednesday nights. See the Online Course Schedule for details. Use the Registration Form for Online Courses for this section.

5502.  Regulation of Medical Devices:  Submissions (990) crn:  8589  There is an online section of Regulation of  Medical Devices:  Submissions  on Wednesday nights. See the Online Course Schedule for details. Use the Registration Form for Online Courses for this section.

5508.  Good Pharmacovigilance Operations (111) crn:  8585
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 (990) crn:  5870  There is an online section of Good Pharmacovigilance Operations on Thursday nights. See the Online Course Schedule for details. Use the Registration Form for Online Courses for this section.

5508. Good Pharmacovigilance Operations (991) crn: 8785 These is an online section of Good Pharmacovigilance Operations on Tuesday nights. See the Online Course Schedule for details. Use the Registration Form for Online Courses for this section.

5515.  Biologics/Biosimilars: A Regulatory Overview (990)  crn:  8579  There is an online section of Biologics/Biosimilars:  A Regulatory Overview on Monday nights. See the Online Course Schedule for details. Use the Registration Form for Online Courses for this section.

5516.  Cleaning Validation (990) crn: 3422 There is an online section of Cleaning Validation on Tuesday nights. See the Online Course Schedule for details. Use the Registration Form for Online Courses for this section.

5533.  Requirements for Product Labeling and Advertising (990) crn:  5871  There is an online section of Requirements for Product Labeling and Advertising on Thursday nights. See the Online Course Schedule for details. Use the Registration Form for Online Courses for this section.

5536.  Good Clinical Practices (990) crn:  3423 There is an online section of Good Clinical Practices on Tuesday nights. See the Online Course Schedule for details. Use the Registration Form for Online Courses for this section. CLOSED. WAIT LIST ONLY.

5537.  Clinical Trial Management (990) crn: 5872  There is an online section of Clinical Trial Management on Wednesday nights. See the Online Course Schedule for details. Use the Registration Form for Online Courses for this section.

5538.  Clinical Drug Safety and Pharmacovigilance (111) crn: 7673
Hands-on experience with Argus Oracle will be included.
Meets 3 weekends (Saturday and Sunday):
8:30 am – 4:00 pm Sat (1/2 hour lunch): May 19, June 2 & 16.
9:00 am – 2:30 pm Sun (1/2 hour lunch): May 20, June 3 & 17.
Make-up date:  June 23 (Saturday)
In-class, proctored exam:  Sunday: June 17 or 24
Faculty:  S. Thapar
No required text.

5539.  Global Clinical Drug Development (111) crn: 8586
Prerequisite: two of the following courses: Drug Development (5459) or Good Clinical Practices (5536) or Food and Drug Law (5592) or Global Regulatory Affairs (5591).
8:30 am - 5:00 pm Sundays (1 hour lunch):  June 3, 10, 24, July 1, 15.  Meets 5 times plus final exam.  Make-up, if needed, July 22.
In-class, proctored exams:  June 24 and July 15. 
Faculty:  L. Edwards
Required text:  Principles and Practices of Pharmaceutical Medicine, 3rd edition, (ISBN: 978-1-4051-9472-3).
Available on the Paley Library website for registered students: http://vv4kg5gr5v.search.serialssolutions.com/?V=1.0&L=VV4KG5GR5V&S=JCs&C=TC0000441153&T=marc
Not open to students who have taken Pharmaceutics 539.

5545.  Post Approval Changes (PAC) (990) crn: 7677 There is an online section of Post Approval Changes on Wednesday nights. See the Online Course Schedule for details. Use the Registration Form for Online Courses for this section.

5579.  Legal and Regulatory Basis of Pharmacovigilance (111) crn:  5946
Hands-on experience with Argus Oracle will be included.
Suggested Prerequisite: One Pharmacovigilance course:  Either (5571) or  (5538) or (5508) or (5578). 
Meets 3 weekends (Saturday and Sunday):
8:30 am – 4:00 pm Sat (1/2 hour lunch): July 14, 28 & Aug 4.
9:00 am – 2:30 pm Sun (1/2 hour lunch): July 15, 29 & Aug 5.
Make-up date:  Aug 11 (Saturday)
In-class, proctored exam:  Sunday: Aug 5 or 12
Faculty:  S. Thapar
No required text.

5591.  Global Regulatory Affairs (990) crn: 1733   There is an online section of Global Regulatory Affairs on Tuesday nights. See the Online Course Schedule for details. Use the Registration Form for Online Courses for this section.

5592.  Food and Drug Law (111) crn:  8587
8:30 am - 3:00 pm Saturdays (1/2 hour lunch): May 19, June 2, 9, 23, 30, July 14. Meets 6 times plus final exam.
Make-up, if needed, July 21.
In-class, proctored exam:  June 23.
Faculty:   B. Berger
Required text: Food and Drug Law: Cases and Materials, 4th ed, 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.

5592.  Food and Drug Law (112) crn:  8588
6:00 pm - 9:30 pm Tuesdays:  May 29, June 5, 12, 19, 26, July 10, 17, 24, 31, Aug 7.  Meets 10 times plus final exam. No class July 3.  Make-ups, if needed, Aug 14 or 21.
In-class, proctored exam:  June 19.
Faculty:  C. Hammes
Required text: Food and Drug Law: Cases and Materials, 4th edition, Hutt, et al, Foundation Press, (ISBN:  1609301757).  Only purchase the 4th edition (not earlier editions).
Suggested text: Statutory Supplement, Hutt, West Academic Publishing, 2018, (ISBN: 978-1-63460-289-1).  Note: a 2014 or later edition is acceptable. Students may also download the supplement from the FDA website.
Assignment for first class:
Read pp 1 – 25 of Food and Drug Law: Cases and Materials and be prepared to discuss. Download and bring the U.S. Constitution to the first class:  www.archives.gov/exhibits/charters/constitution_transcript.html
Not open to students who have taken Pharmaceutics 592.

5592.  Food and Drug Law (990) crn: 1734 There is an online section of Food and Drug Law on Tuesday nights. See the Online Course Schedule for details. Use the Registration Form for Online Courses for this section.

5592.  Food and Drug Law (991) crn: 5886 There is an online section of Food and Drug Law on Wednesday nights. See the Online Course Schedule for details. Use the Registration Form for Online Courses for this section.

5595.  Food Law (990)  crn: 8583  There is an online section of Food Law on Wednesday nights. See the Online Course Schedule for details. Use the Registration Form for Online Courses for this section.

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Registration Form for Traditional Courses at Fort Washington

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

How to Register

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

Is this your fourth class in 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 RA and QA? 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
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
 Or, phone: 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.

 

Temple University RA and QA homepage

 
Temple University School of Pharmacy
Regulatory Affairs and Quality Assurance (RA and QA) Graduate Program

425 Commerce Drive, Suite 175
Fort Washington, PA  19034-2713
Phone: 267.468.8560
E-Mail:
qara@temple.edu

 

We have changed our name from Quality Assurance/Regulatory Affairs (QA/RA) to the Regulatory Affairs and Quality Assurance Graduate Program (RA and QA) due to Search Engine issues.

This schedule is subject to change.