collapse allexpand all
Regulatory Science (RSCI)
Audit requirements mandated by the FDA and other international regulatory agencies, including internal, external, regulatory agency, third party, GMP, GLP, ISO 13485/QSR and supplier audits.
| Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
|---|---|---|---|---|---|---|---|---|---|
| 49106D | 679 | Lecture | TBA | TBA | 11 of 50 | Nancy Pire-Smerkanich,Eunjoo Pacifici,Frances Richmond | OFFICE & ONLINE |  |
Fundamentals and applications of Statistical Process Control (SPC) in development and monitoring of manufacturing processes; includes SPC in root cause analysis and CAPA.
| Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
|---|---|---|---|---|---|---|---|---|---|
| 49107D | 679 | Lecture | TBA | TBA | 13 of 50 | Keith Morel, Eunjoo Pacifici,Frances Richmond | OFFICE & ONLINE | |
Current problems in regulatory affairs, legal management, preclinical and clinical testing, scientific evaluation and quality assurance. (Duplicates credit in former MPTX 521.) Graded CR/NC. Recommended preparation: undergraduate degree in pharmacy, medical or independent health sciences, engineering or equivalent mix of post secondary training and industry experience; enrollment in MS Regulatory Science program.
| Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
|---|---|---|---|---|---|---|---|---|---|
| 49111D | 695 | Lecture | TBA | TBA | 3 of 50 | Susan Bain, Eunjoo Pacifici,Frances Richmond | OFFICE & ONLINE | | |
| 49121D | 626 | Lecture | TBA | TBA | 8 of 50 | Chiaoyun Kuo, Eunjoo Pacifici,Frances Richmond | OFFICE & ONLINE | | |
| 49122D | 679 | Lecture | TBA | TBA | 7 of 50 | Nancy Pire-Smerkanich,Eunjoo Pacifici,Frances Richmond | OFFICE & ONLINE | | |
| 49123D | 892 | Lecture | TBA | TBA | 8 of 50 | Eunjoo Pacifici,Frances Richmond | OFFICE & ONLINE | |
Research leading to the master's degree. Maximum units which may be applied to the degree to be determined by the department. Graded CR/NC.
| Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
|---|---|---|---|---|---|---|---|---|---|
| 49115D | 626 | Lecture | TBA | TBA | 8 of 50 | Eunjoo Pacifici,Frances Richmond | OFFICE | | |
| 49116D | 679 | Lecture | TBA | TBA | 0 of 50 | Eunjoo Pacifici,Frances Richmond | OFFICE | |
Part-time or full-time practical work experience in Regulatory Science. The internship must be located at an off-campus facility. Students are individually supervised by faculty. Graded CR/NC. Recommended preparation: Undergraduate or professional degree in pharmacy, medicine or independent health sciences, engineering or equivalent mix of post-secondary training and industry experience; enrollment in MS (Regulatory Science).
| Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
|---|---|---|---|---|---|---|---|---|---|
| 49100D | 626 | Lecture | TBA | TBA | 3 of 50 | Eunjoo Pacifici,Frances Richmond | OFFICE | | |
| 49101D | 679 | Lecture | TBA | TBA | 0 of 50 | Eunjoo Pacifici,Frances Richmond | OFFICE | |
Special topics in Regulatory Science
| Section | Session | Units | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
|---|---|---|---|---|---|---|---|---|---|---|
| Validation Requirements for Medical Products | ||||||||||
| 49119D | 695 | 3.0 | Lecture | TBA | TBA | 6 of 50 | Susan Bain, Eunjoo Pacifici,Frances Richmond | OFFICE & ONLINE | | |
Policies, testing and regulatory requirements affecting commercialization of biologics and novel medical technologies. Focus on biologics, blood and tissue products, radiopharmaceuticals and nanotechnology
| Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
|---|---|---|---|---|---|---|---|---|---|
| 49141D | 626 | Lecture | TBA | TBA | 19 of 50 | Eunjoo Pacifici,Frances Richmond, Susan Bain, Nancy Pire-Smerkanich | OFFICE & ONLINE | |
Statistical and research design methods, data analysis, survey and interview techniques laying the foundation for the dissertation
| Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
|---|---|---|---|---|---|---|---|---|---|
| 49142D | 626 | Lecture | TBA | TBA | 8 of 50 | Frances Richmond, Eunjoo Pacifici | OFFICE & ONLINE | |
Research leading to the doctorate. Maximum units which may be applied towards the degree to be determined by the department. Graded CR/NC
| Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
|---|---|---|---|---|---|---|---|---|---|
| 49118D | 626 | Lecture | TBA | TBA | 1 of 50 | Eunjoo Pacifici,Frances Richmond | OFFICE | |
Dissertation research required for completion of doctoral degree in Regulatory Science.
| Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
|---|---|---|---|---|---|---|---|---|---|
| 49145D | 626 | Lecture | TBA | TBA | 3 of 50 | Eunjoo Pacifici,Frances Richmond | OFFICE | |
Dissertation research required for completion of doctoral degree in Regulatory Science.
- Prerequisite: RSCI 794A
| Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
|---|---|---|---|---|---|---|---|---|---|
| 49146D | 626 | Lecture | TBA | TBA | 2 of 50 | Eunjoo Pacifici,Frances Richmond | OFFICE | |
Dissertation research required for completion of doctoral degree in Regulatory Science.
- Prerequisite: RSCI 794B
| Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
|---|---|---|---|---|---|---|---|---|---|
| 49147D | 626 | Lecture | TBA | TBA | 2 of 50 | Eunjoo Pacifici,Frances Richmond | OFFICE | |
Dissertation research required for completion of doctoral degree in Regulatory Science.
- Prerequisite: RSCI 794C
| Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
|---|---|---|---|---|---|---|---|---|---|
| 49148D | 626 | Lecture | TBA | TBA | 1 of 50 | Eunjoo Pacifici,Frances Richmond | OFFICE | |
Dissertation research required for completion of doctoral degree in Regulatory Science.
- Prerequisite: RSCI 794D
| Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
|---|---|---|---|---|---|---|---|---|---|
| 49149D | 626 | Lecture | TBA | TBA | 0 of 50 | Eunjoo Pacifici,Frances Richmond | OFFICE | |
Preparation for the qualifying exam. Graded CR/NC
| Section | Session | Type | Time | Days | Registered | Instructor | Location | Syllabus | Info |
|---|---|---|---|---|---|---|---|---|---|
| 49144D | 626 | Lecture | TBA | TBA | 10 of 50 | Eunjoo Pacifici,Frances Richmond | OFFICE | |