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 2025 semester. Refer to the main schedule for complete details about assigned faculty, makeup dates, required texts and previous course numbers. Don't forget, you can earn credits at KENX conferences this Spring: 5000. KENX Conferences 1.5 credit hours each section Did you know that you can earn 1.5 credits towards the MS in RAQA by attending specific KENX conferences this spring? Each conference meets over 2.5 days. You attend the sessions marked “Temple Track,” then take a proctored open-book final exam within 6 weeks. For more information on conference topics, see: kenx.org/conferences We will announce the Spring Conference soon. 5459. Drug Development (990) crn: 42713 (ONLINE) – Proctorio Online Proctoring 6:00 pm - 9:00 pm Thursdays: Jan 23, 30, Feb 6, 13, 20, 27, Mar 6, 13, 20, 27, Apr 3, 10. Meets 12 times plus final exam. Make-ups, if needed, Apr 17 (Passover) and 24. Proctored exam: Mar 6 (Proctorio) 5477. Good Manufacturing Practices (990) crn: 3439 (ONLINE) – Proctoring Online Proctoring 6:00 pm - 9:30 pm Thursdays: Jan 23, Feb 6, 13, 20, 27, Mar 6, 13, 20, 27, Apr 3, 10. Meets 10 times plus final exam. No class Jan 30. Make-ups, if needed, Apr 24 and May 1. Proctored exam: Apr 21 (Proctorio) 5509. Pediatric and Orphan Drug Regulations (990) crn: 55323 (ONLINE) – Proctorio Online Proctoring 6:00 pm - 9:00 pm Thursdays: Jan 23, 30, Feb 6, 13, 20, 27, Mar 6, 13, 20, 27, Apr 3, 10. Meets 12 times plus final exam. Make-ups, if needed, Apr 17 (Passover) and 24. Proctored exam: Mar 6 (Proctorio) 5512. Microbiological Concepts in Pharmaceutical Manufacturing (990) crn: 55321 (ONLINE) – Proctorio Prerequisite: strong science background. 6:00 pm – 9:00 pm Thursdays: Jan 23, 30, Feb 6, 13, 20, 27, Mar 6, 13, 20, 27, Apr 3, 10. Meets 12 times plus final exam. Make-ups, if needed, Apr 17 and 24. Proctored exam: May 13 (Proctorio) 5572. Vaccines: RA and QA Issues (990) crn: 45613 (ONLINE) – Proctoring Online Proctoring Prerequisite: Drug Development (5459). Students are also expected to have a college-level background in general biology and chemistry and some knowledge of general microbiology and/or immunology. 6:00 pm - 9:00 pm Thursdays: Jan 23, 30, Feb 6, 13, 20, 27, Mar 6, 13 (recording), 20, 27, Apr 3, 10. Meets 12 times plus final exam. Make-ups, if needed, Apr 17 (Passover) and 24. Proctored exam: Feb 27 (Proctorio) 5578. Risk Management & Safety Signaling of Healthcare Products (990) crn: 53070 (ONLINE) – Proctorio Prerequisite: either 5538 or 5571. 7:00 pm - 10:00 pm Thursdays: Jan 23, 30, Feb 6, 13, 20, 27, Mar 6, 13, 20, 27, Apr 3, 10, 17 (Passover). Meets 12 times plus final exam. Make-ups, if needed, Apr 24 and May 1. Proctored exam: Apr 17. 5612. Bioethics for Pharmaceutical Professionals (990) crn: 28699 (ONLINE) – Proctorio Online Proctoring 6:00 pm – 9:00 pm Thursdays: Jan 23, 30, Feb 6, 13, 20, 27, Mar 6, 13, 20, 27, Apr 3, 10. Meets 12 times plus final exam. Make-ups, if needed, Apr 17 (Passover) and 24. Proctored exam: Mar 6 (Proctorio) AFTERNOON On-CAMPUS COURSE at Fort Washington 5650. Pharmaceutical Regulatory Leadership (101) crn: 53077 (ON-CAMPUS COURSE) Suggested prerequisite: Drug Development (5459) OR Food and Drug Law (5592). 2:00 pm – 5:30 pm Thursdays: Jan 23, 30, Feb 6, 13, 20, 27, Mar 6, 13, 20, 27. Meets 10 times plus final exam. Make-ups, if needed, Apr 3 and 10. In-class, proctored exam: Feb 20. Description: Leading in the pharmaceutical industry requires more than regulatory knowledge: key skills are needed to get the job done with various constituents, including coworkers, employees, and management. This course provides insights, rules, tools and requirements needed to lead in the highly regulated pharmaceutical industry. Students will study organizational principles and practices within the framework of the Code of Federal Regulations (specifically 21 CFR 210, 211, 312, 600 and 820). While these regulations provide what is required, they do not describe how to accomplish it. That task is the job of leadership. Using recommended texts, case studies, class lectures, discussions, and individual research, students will learn how to lead and manage in a regulated industry. Participants will gain the insights to support career goals with new understandings of the work and responsibilities that go along with the titles. Pharmaceutical Science Course 8005. Pharmaceutical Biotechnology (990) crn: 51044 (ONLINE) Strong science background required 6:00 pm – 9:00 pm Thursdays: Jan 23, 30, Feb 6, 13, 20, 27, Mar 6, 13, 20, 27, Apr 3, 10, 17. Meets 12 times plus final exam. Make-up, if needed, Apr 24 and May 1. Proctored exams: Mar 6 and Apr 17 (using Zoom) |