| 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 Spring 2024 semester. Refer to the main schedule for complete details about assigned faculty, required texts and previous course numbers. 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: Computer Systems Validation & Software Assurance, Dec 5-7, San Diego, CA or virtual
https://kenx.orgconferences/2023-computer-systems-validation-software-assurance-university/
5000 (007) crn: 48648 - in person (San Diego)
5000 (990) crn: 53078 - virtual Validation U, March 5 – 7, San Diego, CA, or virtual
5000 (008) crn: 48653 - in person (San Diego)
5000 (991) crn: 48655 - virtual 5459. Drug Development (992) crn: 51026 (ONLINE) RPNow $15.00 Fee
6:00 pm – 9:00 pm Thursdays: 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 and 18.
Proctored exam: Feb 29 (RPNow) 5473. Generic Drug Regulation (ANDAs) (990) crn: 53062 (ONLINE) RPNow $15.00 Fee
Prerequisite: Drug Development (5459).
6:00 pm – 9:00 pm Thursdays: 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 and 18.
Proctored exam: Feb 29 (RPNow) 5474. Process Validation (990) crn: 51030 (ONLINE) RPNow $15.00 Fee
Prerequisites: Strong science background, such as a BS (or higher) in Pharmacy, Chemistry, Biology or Engineering and a basic understanding of pharmaceutical manufacturing processes. RAQA students must
submit their resume for written permission to register.
6:00 pm – 9:00 pm Thursdays: 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 and 18.
Proctored exam: Feb 29 (RPNow) 5477. Good Manufacturing Practices (990) crn: 3439 (ONLINE) RPNow $15.00 Fee
6:15 pm - 9:30 pm Thursdays: Jan 18, 25, Feb 1, 8, 15, 22, Mar 14, 21, Apr 4, 11, 18. Meets 10 times plus final exam. No class Feb 29, Mar 7, or Mar 28. Make-up, if needed, Apr 25.
Proctored exam: Apr 18 (RPNow) 5493. Sterilization Processes (990) crn: 53063 (ONLINE) RPNow $15.00 Fee
Prerequisites: Strong science background. Include resume with registration form.
6:00 pm - 9:00 pm Thursdays: Jan 18, 25, Feb 1, 8, 15, 22, 29, Mar 7, 14, 21 (recording), Apr 4, 11, 18. Meets 12 times plus final exam. No class Mar 28. Make-ups, if needed, Apr 25 and May 2.
Proctored exam: Apr 18 (RPNow) DAYTIME ONLINE COURSE with recordings
5494. Quality Audit (991) crn: 39720 (ONLINE) RPNow $15.00 Fee
Prerequisite: a good practices course: GLPs (5476), GMPs (5477), Advanced GMPs (5479), or GCPs (5536).
Noon - 1:00 pm Tuesdays and Thursdays (Eastern time), plus one hour recording each week, which students must watch before the next scheduled class:
Jan 23, 25 - watch recording before Jan 30
Jan 30, Feb 1 - watch recording before Feb 6
Feb 6, 8 - watch recording before Feb 13
Feb 13, 15 - watch recording before Feb 20
Feb 20, 22 - watch recording before Feb 27
Feb 27, 29 - watch recording before Mar 5
Mar 5, 7 - watch recording before Mar 12
Mar 12, 14 - watch recording before Mar 19
Mar 19, 21 - watch recording before Mar 26
Mar 26, 28 - watch recording before Apr 2
Apr 2, 4 - watch recording before Apr 9
Apr 9, 11 (last live class)
Make-ups, if needed, Apr 16 and 18.
Proctored exam: Mar 7 (RPNow) 5494. Quality Audit (992) crn: 53064 (ONLINE) RPNow $15.00 Fee
Prerequisite: a good practices course: GLPs (5476), GMPs (5477), Advanced GMPs (5479), or GCPs (5536).
6:00 pm – 9:00 pm Thursdays: 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 and 18.
Proctored exam: Mar 7 (RPNow) 5502. Regulation of Medical Devices: Submissions (990) crn: 53065 (ONLINE) RPNow $15.00 Fee
6:00 pm - 9:00 pm Thursdays: 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 and 18.
Proctored exam: Feb 29 (RPNow) 5539. Global Clinical Drug Development (990) crn: 53068 (ONLINE) RPNow $15.00 Fee
6:00 pm – 9:00 pm Thursdays: 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 and 18.
Proctored exam: Feb 29 (RPNow) 5545. Post Approval Changes (PAC) (990) crn: 51047 (ONLINE) RPNow $15.00 Fee
6:00 pm – 9:00 pm Thursdays: Jan 25, Feb 1, 8, 15, 22, 29, Mar 7, 14, 21, 28, Apr 4, 11. Meets 12 times plus final exam. Make-ups, if needed, Apr 18 and 25.
Proctored exam: Mar 7 (RPNow) 5578. Risk Management/Safety Signaling-Healthcare Products (990) crn: 53070 (ONLINE) RPNow $15.00 Fee
Prerequisite: at least one course in Pharmacovigilance (5508, 5538, 5571, 5573, or 5579, or special permission of RAQA Office).
7:00 pm – 10:00 pm Thursdays: Jan 18, 25, Feb 1, 8, 15, 22, 29, Mar 7, 21, 28, Apr 4, 11. Meets 12 times plus final exam. No class Mar 14. Make-ups, if needed, Apr 18 and 25.
Proctored exam: Feb 29 (RPNow) |
