Quality Assurance in Biomedical Product Regulation

Degree:
  • Certificate
Location: Anywhere
Apply Now

Why Quality Assurance for Biomedical Products?

The Graduate Certificate in Quality Assurance for Biomedical Products provides an in-depth knowledge of the global regulatory and compliance requirements for the development, marketing approval and clinical utilization of biomedical products in today’s dynamic global healthcare environment.

The Graduate Certificate in Quality Assurance for Biomedical Products prepares you to navigate the compliance aspects of industry-specific regulatory standards throughout their product lifecycle.

In this program, students will have the opportunity to achieve the following learning outcomes:

  • Describe the general standards utilized by the United States Food and Drug Administration (FDA) and other global regulatory agencies to evaluate the safety and efficacy of existing and new biomedical products utilized by healthcare practitioners in the US market
  • Demonstrate proficiency in the application of compliance associated regulations and standards for global biomedical products throughout their life cycle
  • Differentiate between the distinct stages of the global biomedical product commercialization process from regulatory and standards-based compliance perspectives
  • Detail the fundamental regulatory compliance and standards-based processes under which biomedical products must be manufactured in order to maintain the level of safety and efficacy upon which they were approved for marketing by FDA and other global regulatory agencies

Unique Features

  • Online format provides flexibility for working professionals
  • Choose from elective courses that cover a broad range of practical and relevant issues in the field
  • The BTC4450 Quality Control and Validation Issues course was developed in collaboration with quality assurance professionals from Vertex Pharmaceuticals, and other external pharmaceutical industry partners
  • Courses from this certificate can be applied toward the Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices

What you'll study

General Requirements

Quality Assurance in Biomedical Product Regulation General Requirements
RGA 6000 - Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation
2.00
RGA 6001 - Introduction to Food and Drug Administration Medical Device Regulation
2.00
RGA 6002 - Regulatory Compliance Culture
2.00
RGA 6275 - Product Development and Process Validation
2.00

Electives 

Complete a minimum of 8 quarter hours from the following:

BTC 6210 - Human Experimentation: Methodological Issues Fundamentals
4.00
BTC 6211 - Validation and Auditing of Clinical Trial Information
4.00
RGA 6233 - Application of Quality System Regulation in Medical Device Design and Manufacturing
4.00
RGA 6234 - Drug and Device Supplier Risk Management: Compliance and Processes
4.00
RGA 6462 - Regulatory Compliance in the Pharmaceutical Industry: A Collaborative Approach
4.00

Did You Know?

A graduate certificate can boost your earnings by an average of 25% (Washington Post, 2012).

Did You Know?

137,000 new regulatory affairs jobs will need to be filled by 2018.

Average Time to Completion

1 year

Commitment

Part-Time

Entry Terms

Fall
Spring
Summer
Winter

Meets F-1 Visa Requirements

No