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QA/RA Adobe Connect Classes – Spring 2012
Notes:
You are REQUIRED to purchase headsets for Adobe Connect classes, and you must also test the headset for compatibility with the Adobe Connect system. If your instructor feels a webcam is necessary for class, you are also required to purchase one. We recommend having a webcam to enhance your class presentations.
Students must have any stated prerequisites to register for Adobe classes.
All students new to Adobe must watch: http://breeze.temple.edu/p59716030. You will be given a password at the end, which you must write on your registration form. We will not process registration forms that do not have the password. If you have taken an Adobe class before, you do not need to take the self-test of Adobe, unless you are changing laptops or computers. If you plan to use a different computer, please be considerate of other members in your class and TEST your new computer BEFORE taking a class.
Adobe Connect classes have limited seats. Registration is first-come, first-served. Register NOW to save your spot.
First priority in registration is given to our remote students and then students who are matriculated in the MS program or are close to graduating. The QA/RA Office will make a final determination on registration. Sorry, but once the available seats are taken, we cannot make more space in a class due to licensing limitations. Register NOW to save your spot. We will not process registrations until early January. We delay processing registrations to make sure that your tuition bills are due in mid-March (rather than early December). Save your spot in a class now.
CLASSES ARE LISTED IN EAST COAST TIMES (please adjust according to your time zone).
Spring 2012 - Semester begins January 12
5459. Drug Development (990) crn: 7447 Expectations of Adobe Connect Students. You must use the Adobe Connect registration form for this class.
6:00 pm – 9:00 pm Mondays: Jan 23, 30, Feb 6, 13, 20 (Presidents’ Day), 27, Mar 5, 12, 19, 26, Apr 2, 9. Meets 12 times plus final exam. Make-up, if needed, Apr 16 or 23. Proctored exam: Feb 27 (tentative).
Faculty: Dom Reigle
Required text: New Drug Development: A Regulatory Overview, Mathieu, 8th ed, (ISBN: 1-882615-85-9).
Formerly Pharmaceutics 459. Not open to students who have taken Pharmaceutics 459.
5473. Generic Drug Regulation: ANDAs (990) crn: 12424 Expectations of Adobe Connect Students. You must use the Adobe Connect registration form for this class.
6:00 pm – 9:00 pm Thursdays: Jan 12, 19, 26, Feb 2, 9, 16, 23, Mar 1, 8, 15, 22, 29. Meets 12 times. Make-up, if needed, Apr 5 or 12. Proctored exam: Feb 16 or 23 (tentative).
Faculty: Cindy Ciliberto
No required text.
Formerly Pharmaceutics 483. Not open to students who have taken Pharmaceutics 483.
5473. Generic Drug Regulation: ANDAs (991) crn: 18385 Expectations of Adobe Connect Students. You must use the Adobe Connect registration form for this class.
6:00 pm – 9:00 pm Wednesdays: FIRST LECTURE ONLY on Thurs, Jan 12. Remaining lectures on Wednesdays: Jan 18, 25, Feb 1, 8, 15, 22, 29, Mar 7, 14, 21, 28. Meets 12 times. Make-up, if needed, Apr 4 or 11. Proctored exam: Feb 15 or 22 (tentative).
Faculty: Cindy Ciliberto
No required text.
Formerly Pharmaceutics 483. Not open to students who have taken Pharmaceutics 483.
5477. Good Manufacturing Practices (990) crn: 3439 Expectations of Adobe Connect Students. You must use the Adobe Connect registration form for this class.
6:00 pm – 9:00 pm Thursdays: Jan 19, 26, Feb 2, 9, 16, 23, Mar 1, 8, 15, 22, 29, Apr 12. Meets 12 times plus final exam. No class Apr 5. Make-ups, if needed, Apr 19 and 26. Proctored exam: Feb 23.
Faculty: Evan Boswell
Required text: Good Manufacturing Practices for Pharmaceuticals, 6th ed, Nally (ISBN: 0-8493-3972-3).
Formerly Pharmaceutics 487. Not open to students who have taken Pharmaceutics 487.
5477. Good Manufacturing Practices (991) crn: 12451 Expectations of Adobe Connect Students. You must use the Adobe Connect registration form for this class.
FRIDAY NIGHT section: 9:30 pm - 11:45 pm Fridays: Jan 20, 27, Feb 3, 10, 17, 24, Mar 2, 9, 16*, 23*, 30*, Apr 6*, 13*. Final exam: to be announced. Meets 13 times plus final exam. Proctored midterm and final. International students will be participating in this class. *On March 16 and all subsequent dates, class starts at 10:30 pm – 12:45 am, due to the switch from Daylight’s Savings time.
Faculty: Karen Zimm
No required text.
Formerly Pharmaceutics 487. Not open to students who have taken Pharmaceutics 487.
5494. Quality Audit (990) crn: 7452 Expectations of Adobe Connect Students. You must use the Adobe Connect registration form for this class.
Prerequisite: a good practices course (Pharmaceutics 5476, 5477, 5479, or 5536).
6:30 pm - 9:30 pm Tuesdays: Jan 17, 24, 31, Feb 7, 14, 21, 28, Mar 6, 13, 20, 27, Apr 3. Meets 12 times plus final exam. Make-ups, if needed, Apr 10 or 17. Proctored exam: Feb 21 (tentative). To be announced.
Faculty: Teresa Preziosi
Required text: The ASQ Auditing Handbook, 3rd ed, J.P. Russell. Available from ASQ Quality Audit Division: www.asq.org (ISBN: 9780873896665, ASQ Item 1263).
Formerly Pharmaceutics 494. Not open to students who have taken Pharmaceutics 494.
5496. Regulation of Medical Devices: Compliance crn: 18320 Expectations of Adobe Connect Students. You must use the Adobe Connect registration form for this class.
6:00 pm – 9:00 pm Thursdays: Jan 19, 26, Feb 2, 9, 16, 23, Mar 1, 8, 15, 22, 29, Apr 5. Meets 12 times plus final exam. Make-ups, if needed, Apr 12 and 19. Proctored exam: March 1 (tentative).
Faculty: Marcia Arentz
No required text.
Formerly Pharmaceutics 496. Not open to students who have taken Pharmaceutics 496.
5498. Computer Validation (990) crn: 12428 Expectations of Adobe Connect Students. You must use the Adobe Connect registration form for this class.
6:30 pm – 9:30 pm Mondays: Jan 23, 30, Feb 6, 13, 20 (Presidents’ Day), 27, Mar 5, 12, 19, 26, Apr 2, 9. Meets 12 times plus final exam. Make-ups, if needed, Apr 16 or 23. Proctored midterm: Feb 27 (tentative).
Faculty: Teresa Preziosi
No required text.
Formerly Pharmaceutics 498. Not open to students who have taken Pharmaceutics 498.
5505: Global Medical Device Regulation (990) crn: 12429 Expectations of Adobe Connect Students. You must use the Adobe Connect registration form for this class.
6:00 pm – 9:00 pm Mondays: Jan 23, 30, Feb 6, 13, 20 (Presidents’ Day), 27, Mar 5, 12, 19, 26, Apr 2, 9. Meets 12 times plus final exam. Make-ups, if needed, Apr 16 and 23. Proctored exam: Mar 5 (tentative).
Faculty: Marcia Arentz
No required text.
Formerly Pharmaceutics 505. Not open to students who have taken Pharmaceutics 505.
5508: Good Pharmacovigilance Operations (990) crn: 12452 Expectations of Adobe Connect Students. You must use the Adobe Connect registration form for this class.
DAYTIME section: 8:00 am - 11:00 am Thursdays: Jan 19, Feb 2, 9, 16, 23, Mar 1, 15, 22, 29. Meets 12 times plus final exam. Make-up, if needed, Apr 19. Proctored exam: Mar 1 (tentative). In-class final: Apr 12 (tentative). Class will not meet Jan 26, Mar 8, or Apr 5. However, students will be required to watch recordings of lectures during those weeks and participate in threaded discussions. International students will be participating in this section.
Faculty: Chris Wittrock
No required text.
5536. Good Clinical Practices (990) crn: 7318 Expectations of Adobe Connect Students. You must use the Adobe Connect registration form for this class.
6:00 pm – 9:00 pm Tuesdays: Jan 17, 24, 31, Feb 7, 14, 21, 28, Mar 6, 13, 20, 27, Apr 3. Meets 12 times plus final exam. Make-ups, if needed, Apr 17. Proctored exam: April 10 (tentative).
Faculty: Nancy Smith
Required text: 2010 CFR/ICH GCP Reference Guide. Order from www.barnettinternational.com. Students may use the 2005/06 version or any subsequent version.
Formerly Pharmaceutics 536. Not open to students who have taken Pharmaceutics 536.
5575. Regulatory Sciences (990) crn: 12430 Expectations of Adobe Connect Students. You must use the Adobe Connect registration form for this class.
Prerequisite: a strong science background. Fax resume to the QA/RA Office (267.468.8565) for approval.
6:00 pm – 9:00 pm Thursdays: Jan 19, 26, Feb 2, 9, 16, 23, Mar 1, 8, 15, 22, 29, Apr 5. Meets 12 times plus final exam. Make-ups, if needed Apr 12 and 19. Proctored exam: Feb 16 (tentative).
Faculty: Thomas Schultz
No required text.
Formerly Pharmaceutics 580. Not open to students who have taken Pharmaceutics 580.
5592. Food and Drug Law I (990) crn: 9424 Expectations of Adobe Connect Students.You must use the Adobe Connect registration form for this class.
6:00 pm – 9:00 pm Tuesdays: Jan 17, 24, 31, Feb 7, 14, 21, 28, Mar 6, 13, 20, 27, Apr 3. Meets 12 times plus final exam. Make-ups, if needed, Apr 10 or 17. Proctored exam: tba.
Faculty: Gail Pilgrim
Required text: Food and Drug Law: Cases and Materials, 3rd ed, Hutt, et al, Foundation Press, 2007, (ISBN: 978-
1-58778-068-4). Order the 2007 edition and not earlier versions.
Formerly Pharmaceutics 592. Not open to students who have taken Pharmaceutics 592.
5594. Regulation of Dietary Supplements, Botanicals, and Nutraceuticals (990) crn: 12431 Expectations of Adobe Connect Students. You must use the Adobe Connect registration form for this class.
6:00 pm – 9:00 pm Wednesdays: Jan 18, 25, Feb 1, 8, 15, 22, 29, Mar 7, 14, 21, 28, Apr 4. Meets 12 times plus final exams. Make-ups, if needed, Apr 11 or 18. Proctored midterm: Feb 29.
Faculty: Alexa Smith
Required text: Regulation of Functional Foods and Nutraceuticals, Clare M. Hasler, Editor
Formerly Pharmaceutics 594. Not open to students who have taken Pharmaceutics 594.
5601. Industry Interactions with FDA and Health Authorities (990) crn: 8726 Expectations of Adobe Connect Students. You must use the Adobe Connect registration form for this class. CLOSED! WAIT LIST ONLY!
6:00 pm – 9:00 pm Tuesdays: Jan 17, 24, 31, Feb 7, 14, 21, 28, Mar 6, 13, 20, 27, Apr 3. Meets 12 times plus final exam. Make-up, if needed, Apr 10 or 17. Proctored exam: Feb 21 (tentative).
Faculty: Alan Traettino
Required text: How to Work with the FDA – Tips From Experts, Wayne Pines, Second Edition, FDLI. FDLI will give QA/RA students a special student discount only if you order by phone from FDLI’s Customer Service Department (1-800-956-6293) or fax (202-371-0649). You must include a copy of your Temple QA/RA schedule. Do not complete your transaction on-line or you will be charged the prices listed for non-members.
Formerly Pharmaceutics 601. Not open to students who have taken Pharmaceutics 601.
5605. Advanced Topics in Food and Drug Law (990) crn: 12432 Expectations of Adobe Connect Students. You must use the Adobe Connect registration form for this class.
Prerequisite: Food and Drug Law I (Pharmaceutics 5592).
6:00 pm – 9:00 pm Wednesdays: Jan 18, 25, Feb 1, 8, 15, 22, 29, Mar 7, 14, 21, 28, Apr 4. Meets 12 times plus final exam. Make-ups, if needed, Apr 11 or 18. Proctored exam: tba.
Faculty: Gail Pilgrim
Required texts: 1) Food and Drug Law: Cases and Materials, 3rd ed, Hutt, et al, Foundation Press, 2007, (ISBN: 978-
1-58778-068-4). Order the 2007 edition and not earlier versions; AND 2) The Generic Challenge: Understanding Patents, FDA and Pharmaceutical Life-Cycle Management, Voet, 3rd ed, paperback, $28.95.
Formerly Pharmaceutics 605. Not open to students who have taken Pharmaceutics 605.
5612. Bioethics for Pharmaceutical Professionals (990) crn: 12433 Expectations of Adobe Connect Students. You must use the Adobe Connect registration form for this class.
6:00 pm – 9:00 pm Wednesdays: Jan 18, 25, Feb 1, 8, 15, 22, 29, Mar 7, 14, 21, 28, Apr 4. Meets 12 times plus final exam. Make-ups, if needed, Apr 11 or 18. Proctored exam: Feb 29 (tentative).
Faculty: Elora Weringer
Required text: Bioethics: An Introduction to the History, Methods, and Practice, Jecker, 2nd ed, 2007, Jones & Bartlett Learning (ISBN: 0763743143).
Formerly Pharmaceutics 610. Not open to students who have completed Pharmaceutics 610.
8004. Pharmaceutical Manufacturing II: Solid Dosage Forms (990) crn: 12443 Expectations of Adobe Connect Students. You must use the Adobe Connect registration form for this class.
Strong science background required. Fax resume to the QA/RA Office (267.468.8565) for approval.
7:00 pm – 10:00 pm Wednesdays: Jan 25, Feb 1, 8, 15, 22, 29, Mar 7, 14, 21, 28, Apr 4, 11. Meets 12 times plus proctored exam. Make-up, if needed, April 18. Proctored exam: Feb 22 (tentative).
Faculty: Karen Zimm
No required text.
Formerly Pharmaceutics 407. Not open to students who have taken Pharmaceutics 407.
Students MUST use the CONNECT REGISTRATION FORM for CONNECT classes.
Is this your first registration with Temple? If
so, you must include a RESIDENCY
FORM
Is this your fourth class with the QA/RA 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: qara@temple.edu
Or, mail your forms to:
Temple University
QA/RA Graduate Program
425 Commerce Drive, Suite 175
Ft. Washington, PA 19034
To receive a complete refund for a course, you must notify the
QA/RA 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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