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In addition to meeting the requirements for classified graduate standing and the basic requirements for the master's degree as described in Part Two of the Graduate Bulletin, the student must complete a graduate program consisting of a minimum of 40 units as follows.

Complete 25 units of required courses:

RA 601 The Pharmaceutical, Biotechnology and Medical Device Industries (3)
RA 602 Introduction to Food and Drug Law (3)
RA 705 Project Planning for the Biomedical Industry

RA 770 Current Good Manufacturing Practice - General Concepts (3)
RA 774 Investigational and Marketing Applications for Drugs, Biologics & Medical Devices (3)
RA 799A Thesis or Project (3)
BA651 Organizational Behavior (2)
BA 662 Operations Management (2)
IDS 705 Communications Strategies (3)

Complete 15 units of electives, at least 12 units of which must be chosen from Category A:

Category A

RA 696 Advanced Topics in Regulatory Affairs (1-4)
RA 771 Current Good Manufacturing Practice - Advanced Topics (3)
RA 772 Post-Approval Activities, Including FDA Advertising, Promotion and Labeling (3)
RA 773 Medical Device Regulations (3)
RA 775 Clinical Trials: Issues in Design, Conduct and Evaluation (3)
RA 776 Validation of Pharmaceuticals, Biologics and Medical Devices (3)
RA 778 Quality Control and Quality Assurance: Pharmaceuticals, Biologics, and Medical Devices (3)

RA 779 International Medical Regulations (3)

RA 781 Practical Ethics for Healthcare Professsionals (3)
RA 797 Research (1-3)
RA 798 Special Study (1-3)

Category B

MGT 701 Organizational Theory and Design (3)
MGT 721 Seminar in Group Processes and Leadership (3)
MGT 741 Seminar in Organization Power and Politics (3)
IDS 741 Seminar in Systems Assessment & Deployment for Total Quality Management (3)
IDS 744 Seminar in Total Quality Management and Productivity (3)
IDS 754 Seminar in Production and Operations Management (3)

Category C

Selected courses at California Western School of Law

 


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Master of Science in
Regulatory Affairs
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Program Description
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Advanced Certificate in
Regulatory Affairs
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Program Description
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Courses for Advanced Certificate
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Certificate of Completion
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