Temple University logo

Summer 2021 Thursday Classes (RAQA)

 

KENX CONFERENCE COURSES OPEN TO STUDENTS
(Remember, you can take a KENX course On-Demand, fitting it around your schedule…)
5000. KENX Conference Topics (1.5 credits each) (007) crn: 11575 Expectations of Online Students. Use the Registration Form for Online Courses for this course.
Refer to the RAQA website for different conference topics and meeting dates, including Cleaning Validation, Environmental Monitoring, Disinfection OR Laboratory, Analytical and Stability Issues AND more!
Conferences may be attended in person, or lectures may be watched on-Demand over a 6-week period.

5459.  Drug Development (992) crn: 7675 (ONLINE) Expectations of Online Students. Use the Registration Form for Online Courses for this course.
This course will use PSI Services LLC’s RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to PSI via credit card at the start of the proctored exam.
6:00 pm – 9:00 pm Thursdays:  May 20, 27, June 3, 10, 17, 24, July 1 (possible recording), 8, 15, 22, 29, Aug 5.  Meets 12 times plus final exam.  Make-ups, if needed, Aug 12 and 19.
Proctored exam:  June 24 (RPNow)
Faculty:  C. Merck
Required text:  to be announced.
Not open to students who completed RAQA 459.

5473.  Generic Drug Regulation:  ANDAs (990) crn: 8584 (ONLINE) Expectations of Online Students. Use the Registration Form for Online Courses for this course.
This course will use PSI Services LLC’s RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to PSI via credit card at the start of the proctored exam.
Prerequisite:  Drug Development (5459)
6:00 pm – 9:00 pm Thursdays:  May 20, 27, June 3, 10, 17, 24, July 1 (possible recording), 8, 15, 22, 29, Aug 5.  Meets 12 times plus final exam.  Make-ups, if needed, Aug 12 and 19.
Proctored exam:  June 24 (RPNow)
Faculty:  C. Ciliberto
No required text.
Not open to students who completed RAQA 483.

5477.  Good Manufacturing Practices (992) crn: 11566 (ONLINE) Expectations of Online Students. Use the Registration Form for Online Courses for this course.
This course will use PSI Services LLC’s RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to PSI via credit card at the start of the proctored exam. 
6:00 pm – 9:00 pm Thursdays: May 20, 27, June 3, 10, 17, 24, July 1, 8, 15, 22, 29, Aug 5.  Meets 12 times plus final exam.  Make-ups, if needed, Aug 12 and 19.
Proctored exam: June 24 (RPNow)
Faculty:  R. Phillips
No required text.
Not open to students who have completed RAQA 487.

5494.  Quality Audit (990) crn: 4137 (ONLINE) Expectations of Online Students. Use the Registration Form for Online Courses for this course.
This course will use PSI Services LLC’s RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to PSI via credit card at the start of the proctored exam. 
Prerequisite:  a good practices (GxP) course: GLPs (5476), GMPs (5477), Advanced GMPs (5479), or GCPs (5536).
7:00 pm – 10:00 pm Thursdays: May 20, 27, June 3, 17, 24, July 1, 8, 15, 22, 29, Aug 5, 12, 19. Meets 12 times plus final exam. No class June 10.  Make-ups, if needed, Aug 26 and Sept 2.
Proctored exams:  July 8 and Aug 19 (RPNow).
Faculty:  J. Werrmann
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 completed RAQA 494.

5497.  Statistics for Clinical Trials (990) crn: 10675 (ONLINE) Expectations of Online Students. Use the Registration Form for Online Courses for this course.
This course will use PSI RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to PSI via credit card at the start of the proctored exam. 
6:00 pm – 9:00 pm Thursdays:  May 20, 27, June 3, 10, 17, 24, July 1, 8, 15, 22, 29, Aug 5.  Meets 12 times plus final exam.  Make-ups, if needed, Aug 12 and 19.
Proctored exam:  July 1 (RPNow)
Faculty:  K. Weiss
No required text.
Not open to students who have completed RAQA 497.

5498. Computerized Systems Validation (990) crn: 11568 (ONLINE) Expectations of Online Students. Use the Registration Form for Online Courses for this course.
This course will use PSI RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to PSI via credit card at the start of the proctored exam. 
12:00 pm - 1:00 pm Tuesdays and Thursdays plus 1 recording weekly (posted Friday) which students watch at their convenience prior to the following class.  Meets:
May 18, 20 - watch recording before May 25
May 25, 27 - watch recording before June 1
June 1, 3 - watch recording before June 8
June 8, 10 - watch recording before June 15
June 15, 17 - watch recording before Jun 22
June 22, 24 (proctored exam) - watch recording before June 29
June 29, July 1 - watch recording before July 6
July 6, 8 - watch recording before July 13
July 13, 15 - watch recording before July 20
July 20, 22 - watch recording before July 27
July 27, 29 – watch recording before Aug 3
Aug 3, 5 – (no recording)
Aug 10 (last class)
Make-ups, if needed, Aug 12, 17.
Proctored exam:  June 24 (RPNow)
Faculty:   T. Preziosi
No required text.
Not open to students who have completed RAQA 498.

5597.  Food GMPs (990) crn: 10662 (ONLINE) Expectations of Online Students. Use the Registration Form for Online Courses for this course.
This course will use PSI Services LLC’s RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to PSI via credit card at the start of the proctored exam. 
6:30 pm – 9:30 pm Thursdays: May 20, 27, June 3, 10, 17, 24, July 1, 8, 22, 29, Aug 5, 12, 26.  Meets 12 times plus final exam. No class July 15. Make-ups, if needed, Sept 2.
Proctored exam: Aug 26 (RPNow).
Faculty:  M. Noonan
No required text.

5611. Regulation of Advertising and Promotions (990) crn: 11573 (ONLINE) Expectations of Online Students. Use the Registration Form for Online Courses for this course.
This course will use PSI Services LLC’s RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to PSI via credit card at the start of the proctored exam. 
6:00 pm – 9:00 pm Thursdays:  May 20, 27, June 3, 10, 17, 24, July 1, 8, 15, 22, 29, Aug 5, 12.  Meets 12 times plus final exam on Aug 12.  Make-ups, if needed, Aug 19 and 26.
Proctored exam:  July 8 (RPNow)
Faculty:  D. Cooke
Required texts:  1) Promotion of FDA-Regulated Medical Products, Hawana, Joanne, Bethany J Hills, Benjamin M Zagarelli, 2019, and 2) Effective Review and Approval of Digital Promotional Tactics, 2nd Edition, Cooke, Dale, 2017.
Not open to students who have completed RAQA 611.