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.

Introductory Regulation

MPTX 511: Introduction to Medical Product Regulation – 3 units

Quality

A minimum of 4 of the following:
RSCI 506: Auditing Principles – 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 515: Quality Systems and Standards – 3 units
MPTX 526: Chemistry and Manufacturing Control – 3 units
MPTX 517: Structure and Management of Clinical Trials – 4 units

Risk Management

1 of the following:
RSCI 520: Risk Management – 2 units
RSCI 527: Medical Product Safety Р3 units

Statistics

RSCI 507: Quality Systems and Statistical Process Controls Р2 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)

RSCI 521: Seminars in Regulatory Science
RSCI 525: Introduction to Drug & Food Toxicology
RSCI 529: Application of Risk Management Tools & Techniques
RSCI 531: Industrial Approaches to Drug Discovery
RSCI 532: Early Stage Drug Development
RSCI 533: Safety Evaluation During Drug Development
RSCI 540: Analysis of Food and Dietary Supplement Regulations
RSCI 541: Drug Development, Reimbursement, and Marketing
RSCI 590: Directed Research
RSCI 596: Internship for Curricular Practical Training in Regulatory Science
RSCI 601: Biomedical Commerce
RSCI 606: Regulation of Emerging Technologies & Biological Products
MPTX 512: Regulation of Pharmaceutical & Biological Products
MPTX 513: Regulation of Medical Devices & Diagnostics
MPTX 514: Regulation of Food & Dietary Supplements
MPTX 516: Medical Products & the Law
MPTX 518: Writing Regulatory Drug Submissions
MPTX 519: Global Regulation of Medical Products
MPTX 522: Introduction to Clinical Trial Design & Statistics
MPTX 524: Introduction to Food Science and Technology
MPTX 526: Chemistry Manufacturing and Controls
MPTX 602: Science, Research and Ethics

Total units for degree completion = 32 units