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

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Fall 2017 Schedule for the Regulatory Affairs and Quality Assurance Graduate Program (updated 9/18/17)

On-campus Courses Only - listed 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.

 

 

Special Note:

There are two online courses starting late:

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.

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 (101) crn:  7208
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:  Oct 9.
Faculty:  B. Berger
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 (103)  crn:  34716
8:30 am - 3:00 pm Saturdays (1/2 hour lunch):  Sept 16, 30 (Yom Kippur), Oct 14, 28, Nov 11 (Veterans' Day), Dec 2.  Meets 6 times plus final exam.  Make-up, if needed, Dec 16.
In-class, proctored exam:  Oct 28
Faculty:  P. Smith
Required text:  Drugs: From Discovery to Approval, Ng, 3rd ed, 2015 (ISBN-13:978-1118907276 or ISBN-10: 1118907272).
Recommended:  New Drug Development:  A Regulatory Overview, Mathieu, 8th ed, (ISBN: 1-882615-85-9).
Not open to students who have completed Pharmaceutics 459.

5476.  Good Laboratory Practices (101) crn:  34718
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 (101)  crn:  7177
9:00 am - 3:30 pm Saturdays (1/2 hour lunch):  Sept 16, 30 (Yom Kippur), Oct 14, 28, Nov 11, Dec 2.  Meets 6 times plus final exam.  Make-up, if needed, Dec 16.  
Note:  this class includes a required field trip (date to be announced).
In-class, proctored exam:  Oct 28.
Faculty:  T. Ely
No required text.
Not open to students who have completed Pharmaceutics 487.

5493.  Sterilization Processes:  Manufacturing  (101)  crn:  34752
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 (101)  crn: 32022
Prerequisite:  one good practices course (either GLPs (5476), GMPs (5477), Advanced GMPs (5479) or GCPs (5536).
8:30 am - 3:00 pm Sundays (1/2 hour lunch):  Sept 10, 24, Oct 8 (Columbus Day weekend), 22, Nov 5, 19.  Meets 6 times plus final exam.  Make-up, if needed, Dec 10.
In-class, proctored exam:  Oct 22.
Faculty:  T. Preziosi
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.

5503.  Design Controls for Medical Devices and Combination Products (101)  crn: 32231
8:30 am - 3:30 pm Saturdays (1 hour lunch):  Sept 9, 23, Oct 7 (Columbus Day weekend), 21, Nov 4, 18.  Meets 6 times plus final exam. Make-up, if needed, Dec 9.
In-class, proctored exam:  Oct 21.
Faculty:  T. Genova
No required text.  All readings available on the Internet.

5508.  Good Pharmacovigilance Operations (101)  crn:  34712
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.

5512.  Microbiological Concepts in Pharmaceutical Manufacturing (101)  crn:  34753 For more information, click here.
9:00 am - 5:30 pm Sundays (1 hour lunch):  Sept 17, Oct 1, 15.  Mandatory field trip on Sunday, Nov 12.  Meets 3 Sundays at Fort Washington, plus  mandatory field trip to the Parenteral Drug Association on Nov 12 (bus provided).  Students will also be required to watch a recorded class session and participate in threaded discussions between Sept 17 and Nov 12.  Make-up, if needed, Dec 3.
Proctored exam:  Oct 15.
Faculty:  R. Friedman and T. Ely
No required text.  Suggested text will be mentioned in class.
Not open to students who have taken Pharmaceutics 512.

5536.  Good Clinical Practices (101)  crn:  28583
6:00 pm - 9:30 pm Tuesdays:  Sept 12, 19, 26, Oct 3, 10, 17, 24, 31, Nov 7, 14.  Meets 10 times plus final exam.  Make-ups, if needed, Nov 21 or 28.
In-class, proctored exam:  Oct 10.
Faculty:  P. Sax
No required text.  Students may purchase 2016 CFR/ICH GCP Reference Guide.  Order from www.barnettinternational.com.  Or, they may also obtain the same regulations through Internet sources.
Not open to students who have taken Pharmaceutics 536.

5536.  Good Clinical Practices (102)  crn:  32000
8:30 am - 5:00 pm Saturdays (1 hour lunch):  Sept 16, 30 (Yom Kippur), Oct 14, 28, Nov 11 (Veterans' Day).  Meets 5 times plus final exam.  Make-up, if needed, Dec 2.
In-class, proctored exams: Oct 14 and Nov 11.
Faculty:  L. Edwards
Required text:  Principles and Practices of Pharmaceutical Medicine, 3rd ed, (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 536.

5538.  Clinical Drug Safety and Pharmacovigilance (101)  crn:   34713
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:  GCPs (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, ISBN:  978-1-119-96726-2).
Not open to students who have taken Pharmaceutics 538 or 5571.

5539.  Global Clinical Drug Development (101) crn:  23451
Prerequisites:  Permission of the RAQA Office (submit current CV) or, students must have completed two of the following courses:  Drug Development (5459), GCPs (5536), Food and Drug Law (5592) or Global Regulatory Affairs (5591). 
8:30 am - 5:00 pm Sundays (1 hour lunch):  Sept 17, Oct 1, 15, 29, Nov 12.  Meets 5 times plus final exam.  Make-up, if needed, Dec 3.
In-class, proctored exams: Oct 15 and Nov 12.
Faculty:  L. Edwards
Required text:  Principles and Practices of Pharmaceutical Medicine, 3rd ed, (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.

5544.  Regulatory Intelligence (101)  crn:  34754 For more details, click here.
Prerequisites:  Drug Development (5459) and Food and Drug Law (5592).
8:30 am - 4:30 pm Sundays (1/2 hour lunch):  Sept 17, Oct 1, 15, 29, Nov 12.  Meets 5 times plus final exam.  Make-up, if needed, Dec 3.
In-class, proctored exams:  Oct 15 and 29.
Faculty:  L. Bowen
No required text.

5574.  Pharmaceutical Quality Management Systems (101) crn:  28860
Prerequisite:  Drug Development (5459).
6:00 pm - 9:30 pm Wednesdays: Sept 13, 20 (Rosh Hashanah), 27, Oct 4, 11, 25, Nov 1, 8, 15, 29.  No classes Oct 18 and Nov 22.  Meets 10 times plus final exam.
Make-ups, if needed, Dec 6 or 13.
In-class, proctored exam:  Oct 25.
Faculty:  M. LaBruto
Required text:  Quality Systems and Control for Pharma-ceuticals, Sarkar, Dipak, K., 2008 (ISBN:  0789015838).

5577.  Global CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics (101)  crn: 34748
6:00 pm - 9:30 pm Thursdays:  Sept 14, 21, 28, Oct 5, 12, 19, 26, Nov 2, 9, 16.  Meets 10 times plus final exam.  Make-ups, if needed, Nov 30 or Dec 7. One or more classes may be recordings instead of on-campus meetings.
In-class, proctored exam:  Oct 12.
Faculty:  K. Surowitz
Required text:  The Challenge of CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics, John Geigert, 2nd ed, Springer, 2014.

5579.  Regulatory and Legal Basis of Pharmacovigilance (101)  crn:    28586
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).   No class Nov 22.  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.

5592.  Food and Drug Law (101) crn:  20849
8:30 am - 3:00 pm Saturdays (1/2 hour lunch):  Sept 9, 23, Oct 7 (Columbus Day weekend), 21, Nov 4, 18.  Meets 6 times plus final exam.  Make-up, if needed, Dec 9.
In-class, proctored exam:  Oct 7.
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 (102) crn:  25891
6:00 pm - 9:30 pm Thursdays:  Sept 14, 21, 28, Oct 5, 12, 19, 26, Nov 2, 9, 16.  Meets 10 times plus final exam.  Make-ups, if needed, Nov 30 or Dec 7.
In-class, proctored exam:  Oct 12.
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.

5597.  Food Good Manufacturing Practices (101)  crn:  32025
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.

5612.  Bioethics for Pharmaceutical Professionals (101)  crn:   34757
8:30 am - 3:00 pm Saturdays (1/2 hour lunch):  Sept 16, 30 (Yom Kippur), Oct 14, 28, Nov 11 (Veterans' Day), Dec 2.  Meets 6 times plus final exam.  Make-up, if needed, Dec 16. 
In-class, proctored exam:  Oct 28.
Faculty: C. Wittrock
Required text:  Bioethics:  Principles, Issues, and Cases, Vaughn, 3rd edition, 2017, Oxford University Press, ISGN13:  978019025012, ISBN10: 0190250100.
Not open to students who have taken Pharmaceutics 610.

5622.  Unit Operations (101)  crn:  25915
Prerequisites:  strong science background, including familiarity with chemistry, biology, and physics.  Basic understanding of pharmaceutical manufacturing processes also required, in addition to aptitude in basic mathematical principles, including the ability to do calculations.
This course includes mandatory field trips to Emerson Labs (Oct 7 and 21) where students participate in manufacturing operations.  Class size is limited to the first six students who register. 
8:00 am - 3:00 pm Saturdays (1/2 hour lunch):  Sept 9, 23, Oct 7 (Columbus Day weekend), 21, Nov 4, 18 (in-class, final exam).  Meets 5 times plus final exam.  Mandatory field trips to Emerson Labs on Oct 7 and 21. Make-up date, if needed, Dec 9.
In-class, proctored exam:  Nov 18.
Faculty:  W. McVay
Required text:  Pharmaceutical Process Engineering, Hickley and Genderton, (ISBN: 0-824700298-0).
Supplemental text:  Pharmaceutical Process Design and Management, K. McCormick, W. McVay, Gower Publishing Ltd, 2012 [ISBN: 978-1-4094-2711-7  (hardback) or 978-1-4094-2712-4 (electronic version)]. Available at ashgate.com/Business (left menu), then click Pharmaceutical Industry (right menu).

Non-Thesis MS Courses Available to RAQA Students

Electives from the non-thesis MS in Pharmaceutics program are open to RAQA students who have strong science backgrounds. This consists of a minimum of 2 years of general chemistry, including organic and one analytical chemistry course. Students must include their resume with their registration form.

Traditional Classroom Course at Fort Washington:
8002.  Pharmaceutical Analysis (1) crn:  17006
Special note:  this required course is only offered in the Fall.  Students should plan accordingly.
5:30 pm - 8:30 pm Mondays: Sept 11, 18, 25, Oct 2, 9 (Columbus Day), 16, 23 (midterm), 30, Nov 6, 13,  27, Dec 4, 11 (final exam).  No class Nov 20.  Meets 12 times plus final exam.  Make-up, if needed, Dec 18.
In-class, proctored exams:  tentatively Oct 23 and Dec 11.
Please note: this schedule lists approximate class meeting dates and is likely to change before the start of the semester. 
Faculty:  D. Canney, A. Fermier, and S. Mehrman.
No required text.
Not open to students who have taken Pharmaceutics 411.

 

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Registration Form for Traditional Courses at Fort Washington

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

 

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