Certificate Programs in Regulatory Science

Our Graduate Certificates are designed to increase your knowledge in certain areas key to medical product development. About four courses in length, each Graduate Certificate can stand alone as a true graduate endpoint, or can be rolled forward after completion into the Master’s or Doctoral program.

The Graduate Certificate in Medical Product Quality is designed for students with a background in biological, pharmaceutical and biomedical sciences and biomedical engineering who seek to expand their expertise in the thriving sector of industry that oversees quality assurance and quality control.

The USC Graduate Certificate in Medical Product Quality requires satisfactory completion of 12 units beyond the baccalaureate degree.

Required Courses

All of the courses offered by the Department of Regulatory and Quality Science can be taken either in-person or online (within the United States). Upon admission we will work with you to develop a course plan that fits your needs. You can find all course descriptions here.

Quality Systems (Choose 1 course)

RSCI 508: Quality Assurance for Drugs & Biologics

RSCI 509: Quality Assurance, Medical Devices & Combination Products

MPTX 515: Quality Systems & Standards

Quality Tools (Choose 1 course)

RSCI 506: Auditing Principles

RSCI 507: Quality Systems and Statistical Process Control

Managing Complex Projects

RSCI 603: Managing Complex Projects

Quality Assurance or Regulatory Option (Choose 1 course)

MPTX 511: Introduction to Medical Product Regulation

MPTX 515: Quality Systems & Standards

MPTX 519: Global Regulation of Medical Products

RSCI 506: Auditing Principles

RSCI 508: Quality Assurance for Drugs and Biologics

RSCI 509: Quality Assurance, Medical Devices and Combination Products

Graduation Requirements

In order to complete the Graduate Certificate in Medical Product Quality you must have met the following requirements:

  • At least 12 units of required and elective courses
  • Obtained a cumulative GPA of 3.0 or better
  • Maintain continuous enrollment during all fall and spring semesters
  • Complete the certificate within five years

Admission Requirements

Detailed admissions and application information can be found on the Graduate Certificate Admissions Page.

The Graduate Certificate in Clinical Research Design and Management is an ideal training program for individuals interested in clinical research, either at a clinical site or in a medical products company.

The USC Graduate Certificate in Clinical Research Design and Management requires satisfactory completion of 12 units beyond the baccalaureate degree.

Required Courses

All of the courses offered by the Department of Regulatory and Quality Science can be taken either in-person or online (within the United States). Upon admission we will work with you to develop a course plan that fits your needs. You can find all course descriptions here.

MPTX 517: Structure & Management of Clinical Trials

MPTX 522: Introduction to Clinical Trial Design & Statistics

MPTX 602: Science, Research & Ethics

Electives

Any remaining units can be filled with elective coursework chosen from the courses offered by the Department of Regulatory and Quality Sciences.

Suggested Electives

RSCI 506: Auditing Principles

MPTX 511: Introduction to Medical Product Regulation

RSCI 520: Introduction to Risk Management for Health Care Products

RSCI 521: Seminars in Regulatory Science

RSCI 527: Medical Product Safety

RSCI 603: Managing Complex Projects

Graduation Requirements

In order to complete the Graduate Certificate in Clinical Research Design and Management you must have met the following requirements:

  • At least 12 units of required and elective courses
  • Obtained a cumulative GPA of 3.0 or better
  • Maintain continuous enrollment during all fall and spring semesters
  • Complete the certificate within five years

Admission Requirements

Detailed admissions and application information can be found on the Graduate Certificate Admissions Page.

The Graduate Certificate in Food Safety meets a growing need for regulatory and safety experts in food and supplement industries.

The USC Graduate Certificate in Food Safety requires satisfactory completion of 12 units beyond the baccalaureate degree.

Required Courses

All of the courses offered by the Department of Regulatory and Quality Science can be taken either in-person or online (within the United States). Upon admission we will work with you to develop a course plan that fits your needs. You can find all course descriptions here.

MPTX 514: Regulation of Food & Dietary Supplements

MPTX 524: Introduction to Food Science and Technology

RSCI 525: Introduction to Drug & Food Toxicology

Electives

Any remaining units can be filled with elective coursework chosen from the courses offered by the Department of Regulatory and Quality Sciences.

Suggested Electives

RSCI 508: Quality Assurance for Drugs & Biologics

RSCI 509: Quality Assurance, Medical Devices & Combination Products

MPTX 511: Introduction to Medical Product Regulation

MPTX 515: Quality Systems & Standards

MPTX 526: Chemistry Manufacturing and Controls

RSCI 540: Analysis of Food and Dietary Supplement Regulations

Graduation Requirements

In order to complete the Graduate Certificate in Food Science you must have met the following requirements:

  • At least 12 units of required and elective courses
  • Obtained a cumulative GPA of 3.0 or better
  • Maintain continuous enrollment during all fall and spring semesters
  • Complete the certificate within five years

Admission Requirements

Detailed admissions and application information can be found on the Graduate Certificate Admissions Page.

The Graduate Certificate in Patient and Product Safety prepares risk managers and pharmacovigilence experts for professional careers where medical products and facilities have high risks that need to be anticipated and controlled.

The USC Graduate Certificate in Patient and Product Safety requires satisfactory completion of 12 units beyond the baccalaureate degree.

Required Courses

All of the courses offered by the Department of Regulatory and Quality Science can be taken either in-person or online (within the United States). Upon admission we will work with you to develop a course plan that fits your needs. You can find all course descriptions here.

MPTX 602: Science, Research and Ethics

RSCI 520: Introduction to Risk Management for Health Care Products

RSCI 527: Medical Product Safety

RSCI 529: Application of Risk Management Tools & Techniques

Quality Assurance or Regulatory Option (Choose 1 course)

RSCI 506: Auditing Principles

RSCI 508: Quality Assurance for Drugs and Biologics

RSCI 509: Quality Assurance, Medical Devices and Combination Products

MPTX 511: Introduction to Medical Product Regulation

MPTX 515: Quality Systems & Standards

MPTX 519: Global Regulation of Medical Products

RSCI 603: Managing Complex Projects

Graduation Requirements

In order to complete the Graduate Certificate in Patient and Product Safety you must have met the following requirements:

  • At least 12 units of required and elective courses
  • Obtained a cumulative GPA of 3.0 or better
  • Maintain continuous enrollment during all fall and spring semesters
  • Complete the certificate within five years

Admission Requirements

Detailed admissions and application information can be found on the Graduate Certificate Admissions Page.

The Graduate Certificate in Preclinical Drug Development is designed to provide advanced training for individuals interested in preclinical aspects of translational medicine and associated research.

The USC Graduate Certificate in Preclinical Drug Development requires satisfactory completion of 12 units beyond the baccalaureate degree.

Required Courses

All of the courses offered by the Department of Regulatory and Quality Science can be taken either in-person or online (within the United States). Upon admission we will work with you to develop a course plan that fits your needs. You can find all course descriptions here.

RSCI 531: Industrial Approaches to Drug Discovery

RSCI 532: Early Stage Drug Development

RSCI 533: Safety Evaluation During Drug Development

Electives

Any remaining units can be filled with elective coursework chosen from the courses offered by the Department of Regulatory and Quality Sciences.

Suggested Electives

MPTX 511: Introduction to Medical Product Regulation

RSCI 520: Introduction to Risk Management for Health Care Products

RSCI 525: Introduction to Drug & Food Toxicology

MPTX 526: Chemistry Manufacturing and Controls

MPTX 602: Science, Research and Ethics

RSCI 603: Managing Complex Projects

Graduation Requirements

In order to complete the Graduate Certificate in Preclinical Drug Development you must have met the following requirements:

  • At least 12 units of required and elective courses
  • Obtained a cumulative GPA of 3.0 or better
  • Maintain continuous enrollment during all fall and spring semesters
  • Complete the certificate within five years

Admission Requirements

Detailed admissions and application information can be found on the Graduate Certificate Admissions Page.

The Graduate Certificate in Regulatory and Clinical Affairs acquaints individuals with the world of medical product regulation, and prepares them for roles in regulatory and quality aspects of medical product development.

The USC Graduate Certificate in Regulatory and Clinical Affairs requires satisfactory completion of 12 units beyond the baccalaureate degree.

Required Courses

All of the courses offered by the Department of Regulatory and Quality Science can be taken either in-person or online (within the United States). Upon admission we will work with you to develop a course plan that fits your needs. You can find all course descriptions here.

Introductory Course (Choose 1 course)

MPTX 511: Introduction to Medical Product Regulation

RSCI 531: Industrial Approaches to Drug Discovery

RSCI 532: Early Stage Drug Development

Advanced Regulation (Choose 1 course)

MPTX 512: Regulation of Pharmaceutical & Biologic Products

MPTX 513: Regulation of Medical Devices & Diagnostics

MPTX 514: Regulation of Food & Dietary Supplements

Quality Assurance & Risk Management (Choose 1 course)

RSCI 508: Quality Assurance for Drugs & Biologics

RSCI 509: Quality Assurance, Medical Devices & Combination Products

MPTX 515: Quality Systems & Standards

RSCI 520: Introduction to Risk Management for Health Care Products

Electives

Any remaining units can be filled with elective coursework chosen from the courses offered by the Department of Regulatory and Quality Sciences.

Suggested Electives

MPTX 517: Structure & Management of Clinical Trials

MPTX 518: Writing Regulatory Drug Submissions

MPTX 522: Introduction to Clinical Trial Design & Statistics

MPTX 526: Chemistry Manufacturing and Controls

RSCI 525: Introduction to Drug & Food Toxicology

Graduation Requirements

In order to complete the Graduate Certificate in Regulatory and Clinical Affairs you must have met the following requirements:

  • At least 12 units of required and elective courses
  • Obtained a cumulative GPA of 3.0 or better
  • Maintain continuous enrollment during all fall and spring semesters
  • Complete the certificate within five years

Admission Requirements

Detailed admissions and application information can be found on the Graduate Certificate Admissions Page.