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Summer 2021 Monday Classes (RAQA)

 
 

KENX CONFERENCE COURSES OPEN TO STUDENTS
(Remember, you can take these On-Demand, working 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.

5477.  Good Manufacturing Practices (990) crn: 4136 (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 Mondays:  May 17, 24, June 7, 14, 21, 28, July 19, 26, Aug 2, 9, 16, 23, 30. Meets 12 times plus final exam.  No class May 31, July 5, or July 12.  Make-up, if needed:  Wed, Sept 1.
Proctored exam:  Aug 30 (RPNow).
Faculty:  M. Noonan
No required text.
Not open to students who have completed RAQA 487.

5479.  Advanced GMPs – Defining “c” (990) crn:  7676 (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:  successful completion of Good Manufacturing Practices (5477) or permission of the instructor.
6:00 pm – 9:00 pm Mondays:  May 17, 24, 31 (recording), June 7, 14, 21, 28, July 5 (recording), 12, 19, 26, Aug 2.  Meets 12 times plus final exam.  Make-ups, if needed, Aug 9 and 16.
Proctored exam:  June 28 (RPNow)
Faculty:  K. Zimm
No required text.
Not open to students who have completed RAQA 479.

5495.  IND/NDA Submissions (991) crn: 11567 (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. 
Prerequisite: Drug Development (5459) or Food and Drug Law (5592).
6:00 pm – 9:00 pm Mondays:  May 17, 24, 31 (recording), June 7, 14, 21, 28, July 5 (recording), 12, 19, 26, Aug 2.  Meets 12 times plus final exam.  Make-ups, if needed, Aug 9 and 16.
Proctored exam:  June 28 (RPNow).
Faculty:  A. Traettino
Required text: Drugs: From Discovery to Approval, Ng, 3rd edition, 2015 (ISBN-13:978-1118907276 or ISBN-10: 1118907272) OR New Drug Development: A Regulatory Overview, Mathieu, 8th edition, (ISBN: 1-882615-85-9).
Not open to students who have completed RAQA 495.

5537.  Clinical Trial Management (990) crn: 5872 (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:  Good Clinical Practices (5536) or permission of instructor (include resume with registration).
6:00 pm – 9:00 pm Mondays:  May 17, 24, 31 (recording), June 7, 14, 21, 28, July 12, 19, 26, Aug 2, 9. No class July 5. Meets 12 times plus final exam.  Make-ups, if needed, Aug 16 and 23.
Proctored exam: July 12 (RPNow)
Faculty:   J. Scavone
No required text.
Not open to students who have completed RAQA 537.

5591.  Global Regulatory Affairs (990) crn: 1733 (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) or Food and Drug Law (5592).
6:00 pm – 9:00 pm Mondays: May 17, 24, June 7, 14, 21, 28, July 12, 19, 26, Aug 2, 9, 16.  No class May 31 and July 5. Meets 12 times plus final exam.  Make-ups, if needed, Aug 23 and 30.
Proctored exam:  June 28 (RPNow)
Faculty:  D. Larkins
No required text.
Not open to students who have completed RAQA 591.