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Regulatory Affairs & Quality Assurance

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Spring 2025 Tuesday Classes (RAQA)

 

SPRING 2025 - Tuesday Classes

Expectations of Online Students

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Registration Form for On-Campus Courses

 

5477. Good Manufacturing Practices (991) crn:  55325 (ONLINE) – Proctorio Online Proctoring
6:00 pm – 9:00 pm Tuesdays:  Jan 21, 28, Feb 4, 11, 18, 25, Mar 4, 11, 18, 25, Apr 1, 8. Meets 12 times plus final exam.  Make-ups, if needed, Apr 15 (Passover) and 22.
Proctored exam:  Feb 25

5494. Quality Audit (990) crn: 31574 (ONLINE) – Proctorio Online Proctoring
Prerequisite: a good practices course: GLPs (5476), GMPs (5477), Advanced GMPs (5479), or GCPs (5536).
7:00 pm - 10:00 pm Tuesdays: Jan 21, 28, Feb 4, 11, 18, 25, Mar 4, 11, 18, 25, Apr 1, 8, 15 (Passover). Meets 12 times plus final exam. Make-ups, if needed, Apr 22 and 29.  Proctored exam: ​​​​​​ Apr 15 (Proctorio)

5503. Design Controls for Medical Devices & Combination Products (990) crn: 48475 (ONLINE) – Proctorio Online Proctoring
6:00 pm - 9:00 pm Tuesdays:  Jan 21, 28, Feb 4, 11, 18, 25, Mar 4, 11, 18, 25, Apr 1, 8. Meets 12 times plus final exam. Make-ups, if needed, Apr 15 (Passover) and 22.  Proctored exam: Mar 4 (Proctorio)

AFTERNOON COURSE at Fort Washington
5536. Good Clinical Practices (101) crn: 55326 (ON-CAMPUS COURSE)
2:00 pm – 5:30 pm Tuesdays:  Jan 28, Feb 4, 11, 18, 25, Mar 4, 11, 18, 25, Apr 1. Meets 10 times plus final exam. Makeup, if needed, Apr 8.  In-class, proctored exam: Feb 25.

5575. Regulatory Sciences: Managing the Guidelines for Quality (990) crn: 53069 (ONLINE) – Proctorio Online Proctoring
5:30 pm – 8:30 pm Tuesdays:  Jan 21, 28, Feb 4, 11, 18, 25, Mar 4, 11, 25, Apr 1, 8. Meets 12 times plus final exam.  Make-ups, if needed, Apr 15 (Passover) and 22.  Proctored exam:  Mar 4 (Proctorio)

5577. Global CMCs – Biopharmaceuticals and Other Biologics (990) crn: 55328 (ONLINE) – Proctorio Online Proctoring
6:00 pm - 9:00 pm Tuesdays: Jan 21, 28, Feb 4, 11, 18, 25, Mar 4, 11, 18, 25, Apr 1, 8. Meets 12 times plus final exam. Make-ups, if needed, Apr 15 (Passover) and 22. Proctored exam:  Feb 25 (Proctorio)

5592. Food and Drug Law (991) crn: 25838 (ONLINE) – Proctorio Online Proctoring
6:00 pm - 9:00 pm Tuesdays: Jan 21, 28, Feb 4, 11, 18, 25, Mar 4, 11, 18, 25, Apr 1, 8. Meets 12 times plus final exam. Make-ups, if needed, Apr 15 (Passover) and 22. Proctored exam: Mar 4 (Proctorio)

5611. Regulation of Advertising & Promotions (990) crn: 51038 (ONLINE) – Proctorio Online Proctoring
6:00 pm – 9:00 pm Tuesdays: Jan 21, 28, Feb 4, 11, 18, 25, Mar 4, 11, 18, 25, Apr 1, 8, 15 (Passover). Meets 12 times plus final exam. Make-ups if needed, Apr 22 and 29. Proctored exam: Apr 15 (Proctorio)

5650.  Critical Analysis of Media Coverage of the Pharmaceutical Industry (990) crn: 45587 (ONLINE) – Proctorio Online Proctoring
This course has limited enrollment. If you wish to enroll, make sure you forward your registration form early.
6:00 pm – 9:00 pm Tuesdays: Jan 2, 28, Feb 4, 11, 18, 25, Mar 4, 11, 18, 25, Apr 1, 8. Meets 12 times plus final exam. Make-ups, if needed, Apr 15 (Passover) and 22. Proctored exam: Mar 4 (Proctorio) 

5650. Special Topics: Regulation of Artificial Intelligence & Machine Learning (AI/ML) Medical Devices (990) crn:  55327 (ONLINE) - Proctorio Online Proctoring
Prerequisites Drug Development (5459) OR Food and Drug Law (5592).
6:00 pm - 9:00 pm Tuesdays: Jan 21, 28, Feb 4, 11, 18, 25, Mar 4, 11, 18, 25, Apr 1, 8, 15 (Passover).  Meets 12 times plus final exam. Make-ups, if needed, Apr 22 and 29. Proctored exam: Apr 15 (Proctorio)