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) |