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Note: Due to visa requirements, international students must attend courses on-campus, which includes taking online courses in the Ft Washington computer lab.
This is a truncated listing of Thursday courses offered in the RAQA Graduate program during the Fall 2023 semester. Refer to the main schedule for complete details about assigned faculty, required texts and previous course numbers.
ON-CAMPUS Courses
Note: Due to visa requirements, international students must attend courses on-campus, which includes taking online courses in the Ft Washington computer lab.
DAYTIME ON-CAMPUS COURSE at Fort Washington
5459. Drug Development (Fort Washington) (101) crn: 49409
2:00 pm - 5:30 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 and Dec 7.
In-class, proctored exam: Oct 12
ONLINE (ZOOM) COURSES
Don’t forget, KENX Conference courses can be pursued online:
5000. KENX Conferences 1.5 credit hours each section – All sections have the $15.00 RPNow fee
Attend KENX Conferences in-person or On-Demand, or both! On-Demand recordings provide flexibility with completing 18 hours of conference talks at your own pace over 6-weeks. Topics this fall semester include:
Cleaning University, available online
See: https://kenx.org/conferences/cleaning-validation-critical-processes-cleaning-university/
5000 (990) crn: 49580 – virtual
GMP University, available online
See: https://kenx.org/conferences/gmp-university-2023/
5000 (991) crn: 54374 – virtual
Medical Device Validation & Compliance, Oct 24-26, San Diego, CA or virtual
See: https://kenx.org/conferences/medical-device-vv-university/
5000 (009) crn: 54387 – in person (San Diego)
5000 (992) crn: 49581 – virtual
5459. Drug Development (990) crn: 17910 (ONLINE) - RPNow $15.00 fee
6:00 pm - 9:00 pm Thursdays: Sept 14, 21, 28, Oct 5, 12, 19, 26, Nov 2, 9, 16, 30, Dec 7. Meets 12 times plus final exam. No class Nov 23 (Thanksgiving). Make-ups, if needed, Dec 14 and 21.
Proctored exam: Oct 26 (RPNow)
5474. Process Validation (990) crn: 54364 (ONLINE) - RPNow $15.00 fee
Prerequisites: Strong science background: BS (or higher) in Pharmacy, Chemistry, Biology or Engineering and a basic understanding of pharmaceutical manufacturing. Submit resume for written permission to register.
6:00 pm – 9:00 pm Thursdays: Sept 14, 21, 28, Oct 5, 12, 19, 26, Nov 2, 9, 16, 30, Dec 7. Meets 12 times plus final exam. No class Nov 23 (Thanksgiving). Make-ups, if needed, Dec 14 and 21.
Proctored exam: Oct 26 (RPNow)
5477. Good Manufacturing Practices (990) crn: 9357 (ONLINE) - RPNow $15.00 fee
6:15 pm - 9:30 pm Thursdays: Sept 14, 21, 28, Oct 5, 12, 19, Nov 2, 9, 16, 30, Dec 7, 14. Meets 11 times plus final exam. No class Oct 26 or Nov 23 (Thanksgiving). Make-up, if needed, Dec 21.
Proctored exam: Dec 14 (RPNow)
5494. Quality Audit (991) crn: 51968 (ONLINE) - RPNow $15.00 fee CLOSED. WAIT LIST ONLY.
Prerequisite: a good practices course: GLPs (5476), GMPs (5477), Advanced GMPs (5479), or GCPs (5536).
6:00 pm – 9:00 pm Thursdays: Sept 14, 21, 28, Oct 5 (recording), 12, 19, 26, Nov 2, 9, 16, 30, Dec 7. Meets 12 times plus final exam. No class Nov 23 (Thanksgiving). Make-ups, if needed, Dec 14 and 21.
Proctored exam: Oct 26 (RPNow)
5497. Statistics for Clinical Trials (990) crn: 54366 (ONLINE) - RPNow $15.00 fee
No prior knowledge of statistics required. Drug Development (5459) is helpful but not required.
6:00 pm - 9:00 pm Thursdays: Sept 14, 21, 28, Oct 5, 12, 19, 26, Nov 2, 9, 16, 30, Dec 7. Meets 12 times plus final exam. No class Nov 23 (Thanksgiving). Make-ups, if needed, Dec 14 and 21.
Proctored exam: Oct 26 (RPNow)
DAYTIME COURSE
5498. Computerized Systems Validation (990) crn: 54367 (ONLINE) - RPNow $15.00 fee
Noon - 1:00 pm Tuesdays and Thursdays (Eastern time), plus one hour recording each week, which students must watch before the next scheduled class:
Sept 12, 14 - watch recording before Sept 19
Sept 19, 21 - watch recording before Sept 26
Sept 26, 28 - watch recording before Oct 3
Oct 3, 5 - watch recording before Oct 10
Oct 10, 12 – watch recording before Oct 17
Oct 17, 19 - watch recording before Oct 24
Oct 24, 26 - watch recording before Oct 31
Oct 31, Nov 2 - watch recording before Nov 7
Nov 7, 9 - watch recording before Nov 14
Nov 14, 16 - watch recording before Nov 21
Nov 21 and 28 - watch recording before Dec 5, no class Nov 23, Thanksgiving
Dec 5 and 7 (last live class)
Make-ups, if needed, Dec 12 and 14.
Proctored exam: Oct 19 (RPNow)
5508. Good Pharmacovigilance Operations (990) crn: 51972 (ONLINE) - RPNow $15.00 fee
7:00 pm – 10:00 pm Thursdays: Sept 14, 21, 28, Oct 5, 12, 19, 26, Nov 2, 9, 16, 30, Dec 7, 14. Meets 12 times plus final exam. No class Nov 23 (Thanksgiving). Make-up, if needed, Dec 21.
Proctored final exam: Dec 14 (RPNow)
5512. Microbiological Concepts - Pharmaceutical Manufacturing (990) crn: 51973 (ONLINE) - RPNow $15.00 fee
Prerequisites: Strong science background, Food and Drug Law (5592), Any GxPs (5476, 5477, 5479, or 5536)
6:30 pm - 8:00 pm Tuesdays and Thursdays: Sept 19, 21, 26, 28, Oct 3, 5, 10, 12, 17, 19, 24, 26, 31 Nov 2, 7, 9, 14, 16, 21, 28, 30, Dec 5, 7, 12. Meets 24 times plus final exam. No class Nov 23 (Thanksgiving).
Class meets 24 times plus final exam. Make-ups, if needed, Dec 14 and 19.
Proctored exam: Oct 31 (RPNow)
5591. Global Regulatory Affairs (990) crn: 23442 (ONLINE) - RPNow $15.00 fee CLOSED. WAIT LIST ONLY.
Prerequisite: Drug Development (5459) or Food and Drug Law (5592).
6:00 pm - 9:00 pm Thursdays: Sept 14, 21, 28, Oct 5, 12, 19, 26, Nov 2, 9, 16, 30, Dec 7. Meets 12 times plus final exam. No class Nov 23 (Thanksgiving). Make-ups, if needed, Dec 14 and 21.
Proctored exam: Oct 19 (RPNow)
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