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

Fall 2017 Schedule
for the Pharmaceutics Non-Thesis MS Program

Order texts on-line:

Temple U Ambler Bookstore

Students pursuing courses in the Pharmaceutics Non-Thesis Master's Degree are expected to have strong science backgrounds (a minimum of 2 years of general chemistry, including one organic and one analytical chemistry course).

Non-thesis MS students should pursue required courses (see list below*) before taking electives. If you register for courses before formally applying to the master's degree, you must complete at least two required courses before taking any elective.

If you have not been formally accepted into the Pharmaceutics MS program, or if you are a RAQA student who wishes to register for a Pharmaceutical Sciences course, please attach a copy of your resume to your registration form.

Students are expected to take proctored exams on the date listed in the Schedule of Classes. Please check your schedule carefully before registering to make sure you are available on the designated exam date. There is a first time fee of $20 charged to any student who cannot take the exam on the designated date and requests a makeup test; in subsequent semesters, the fee increases to $30 per exam and then $50 per exam. For more information on proctoring and these fees, click here.

Special Schedule Note for Pharmaceutics Non-Thesis Master's Students: Physical Pharmacy (Pharmaceutics 8006) is only offered in the spring semester of even-numbered years. It will be offered again in Spring 2018, so plan your schedule accordingly.

* The required courses in the Non-Thesis MS in Pharmaceutics are:
Pharmaceutical Analysis (8002)
Pharmaceutical Manufacturing I:  Preformulation/Formulation (8003)
Pharmaceutical Manufacturing II: Solid Dosage Forms (8004)
Pharmaceutical Biotechnology (8005)
Physical Pharmacy I (8006)
Applied Biopharmaceutics (8007)

Students in the Pharmaceutics Non-Thesis Master's program may complete either GMPs (Pharmaceutics 5477) or Advanced GMPs - Defining "c" (Pharmaceutics 5479).  They may not receive credit for both.

International students in the non-thesis MS program may take a maximum of one online course per semester and only with special permission of the School's administration.

Schedule Updated Septebmer 18, 2017

 

Online Course:
5474.  Process Validation (990)  crn:  28712 Please use the Registration Form for Online Courses.
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.

On-campus Course at Fort Washington:
Non-Thesis Students may take GMPs (5477) OR Advanced GMPs (5479). They may not receive credit for both.
5477. Good Manufacturing Practices (101)  crn:  7177 Registration Form
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.

Online Course:
Non-Thesis Students may take GMPs (5477) OR Advanced GMPs (5479). They may not receive credit for both.
5477.  Good Manufacturing Practices (990)  crn:   9357 Please use the Registration Form for Online Courses.
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, Dec 4, 11 (proctored final exam).   No class Oct 9 or  Nov 27. Meets 12 times plus final exam.  Make-ups, 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.

Online Course:
Non-Thesis Students may take GMPs (5477) OR Advanced GMPs (5479). They may not receive credit for both.
5477.  Good Manufacturing Practices (991)  crn:   34740 Please use the Registration Form for Online Courses.
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.

On-campus Course at Fort Washington:
5493.  Sterilization Processes:  Manufacturing  (101)  crn:  34752 Registration Form
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.

On-campus Course at Fort Washington:
5512.  Microbiological Concepts in Pharmaceutical Manufacturing (101)  crn:  34753 Registration Form
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.
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.

On-campus Course at Fort Washington:
5577.  Global CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics (101)  crn:  34748 Registration Form
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, Spring, 2013.

On-campus Course at Fort Washington:
5622.  Unit Operations (101)  crn:  25915 Registration Form
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, 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).

On-campus Course at Fort Washington:
8002.  Pharmaceutical Analysis (1) crn:  17006 Registration Form
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.

To register for the On-Campus Courses meeting at Fort Washington, use:
REGISTRATION FORM

To register for the Online Adobe Connect classes use:
REGISTRATION FORM for Online Courses

PRINT AND FAX YOUR REGISTRATION TO: 267.468.8565

Email it to: qarareg@temple.edu

OR, MAIL YOUR REGISTRATION TO:
Temple University
Regulatory Affairs and Quality Assurance Graduate Program
425 Commerce Drive, Suite 175
Ft. Washington, PA 19034

Is this your first registration in the non-thesis MS program? If so, you must fax a RESIDENCY FORM

Will this be your fourth course in the Pharmaceutics program? If so, you must fax a Non-Matriculated Graduate Student Waiver

Join our list serve for the non-thesis Pharmaceutics program to receive updates on schedule postings and to participate in polls!
Email us at qara@temple.

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, available on the Forms link of the RA and QA website.

 

Order texts on-line via: Ambler Campus Bookstore

This schedule is subject to change.
 

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