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Quality Assurance & Regulatory Affairs in Biotechnology (Capstone)

An image of an DNA strand.

Boost your biotech industry knowledge in just one year with UW–Madison’s online Capstone Certificate in Quality Assurance and Regulatory Affairs in Biotechnology.


Is this program right for you?

Biotechnology companies are always looking for talented professionals who not only understand what but more importantly how and why they fit into their company’s global plan of product development, manufacturing and marketing. This capstone certificate is designed to expand upon how and why quality assurance and regulatory affairs are important drivers to any successful team and product launch.

This 100% online program is designed to give talented professionals a competitive edge. With just 9 credits, this certificate program can be completed in 1 year.

You will focus on developing practical and professional quality assurance and regulatory affairs skills needed when working within diverse teams and government agencies. The program is designed in cooperation with biotechnology industry experts, using real-world problems, to prepare you to investigate why problems occur and how to develop strategies to solve them.

Is this program right for you?

Biotechnology companies are always looking for talented professionals who not only understand what but more importantly how and why they fit into their company’s global plan of product development, manufacturing and marketing. This capstone certificate is designed to expand upon how and why quality assurance and regulatory affairs are important drivers to any successful team and product launch.

This 100% online program is designed to give talented professionals a competitive edge. With just 9 credits, this certificate program can be completed in 1 year.

You will focus on developing practical and professional quality assurance and regulatory affairs skills needed when working within diverse teams and government agencies. The program is designed in cooperation with biotechnology industry experts, using real-world problems, to prepare you to investigate why problems occur and how to develop strategies to solve them.

Admissions requirements

All applicants must:

  • Have a bachelor’s degree from an accredited institution.
  • Have a minimum undergraduate GPA of 3.0.
  • Have completed one general biology course with a laboratory at the undergraduate level.
  • Submit evidence of English language proficiency, if applicable. The required proficiency scores are: TOEFL IBT 92, PBT 580; or IELTS 7.0.

Application materials required:

  • Online application
  • Resume/CV
  • Statement of purpose
  • Transcripts
  • Two letters of recommendation

Program highlights

  • Accelerate your career pathway or pivot into biotechnology by practicing how quality assurance and regulatory affairs integrate into all aspects of product development.
  • Investigate real-world scenarios to formulate new strategies.

How you'll learn

  • Fully online curriculum with collaborative online coursework; you choose when you do most of your work each week.
  • Complete three required courses in two or three semesters. You may take more than one topic course, if available, based on your professional goals.
  • Case study format allows you to develop critical thinking and communication skills while learning to negotiate all aspects of product development, from pre-submission to product launch with colleagues, customers and local, state and federal agencies.

Sample curriculum

  • Survey of Quality Assurance and Regulatory Affairs in Biotechnology
  • Topics in Quality Assurance and Regulatory Affairs in Biotechnology
  • Leadership in Quality Assurance and Regulatory Affairs in Biotechnology

Want to sample an online course?

Test drive Canvas, our online learning platform, with modules from an actual UW–Madison master’s program.

Test drive Canvas

Ready to learn more about Quality Assurance & Regulatory Affairs in Biotechnology (Capstone)?
View the UW-Madison Guide

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Our friendly, knowledgeable enrollment coaches are here to answer your questions. Contact an enrollment coach to:

  • Learn how to make this program work with your life/schedule
  • Get help with your application
  • Determine if financial aid is available

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