Required Coursework

MS in Medical Product Quality

Required Coursework

Students will complete a total of 32 units including 21 units of core courses and up to 11 units of electives, which may include an internship.

Introductory Regulation

MPTX511 Introduction to Medical Product Regulation – 3 units

Quality

A minimum of 4 of the following:

MPTX 515 Quality Systems and Standards – 3 units
RSCI 508 Quality Assurance for Drugs and Biologics – 3 units
RSCI 509 Quality Assurance for Medical Devices and Combination Products – 3 units
MPTX 526 Chemistry and Manufacturing Control – 3 units
MPTX 517 Structure and Management of Clinical Trials – 4 units
RSCI 535 Method Development and Validation  –  3 units
RSCI 506 Auditing Principles – 3 units

Risk Management

1 of the following:

RSCI 520 Risk Management – 2 units
RSCI 527 Medical Product Safety – 3 units

Statistics

RSCI 507 Quality Systems and Statistical Process Controls – 2 units

Project Management

RSCI 603 Managing Complex Projects – 3 units
 
Core courses required for degree completion = 21 units

Internship

Students with industry experience generally would not pursue an internship and would take additional elective coursework. Domestic students without prior industry experience can take 2-6 units of internship while international students would enroll in it for 1 unit.

Elective Courses

(up to 11 units can be selected from the following list; other courses appropriate to degree can be considered with approval of Program Director)

MPTX512 Regulation of Drugs and Biologics – 3 units
MPTX513 Regulation of Medical Devices – 3 units
MPTX514 Regulation of Food and dietary Supplements- 3 units
MPTX516 Medical Products and the Law – 3 units
MPTX518 Medical Writing – 3 units
MPTX519 International Approaches to Regulation -3 units
RSCI 521 Seminar in Regulatory Science – 1 unit
MPTX522 Clinical Design Course – 3 units
MPTX524 Food Science and Technology – 3 units
RSCI 525 Introduction to Drug and Food Toxicology – 3 units
RSCI 527 Medical Product Safety – 3 units
RSCI 530 Translational Medicine: An Overview – 2 units
RSCI 531 Drug Discovery – 4 units
RSCI 532 Early Stage Development – 3 units
RSCI 590 Directed Research 1-6 units
RSCI 601 Biomedical Commerce – 4 units
MPTX602 Science, Research, and Ethics – 2 units

Total units for degree completion = 32 units