Online Capstone Certificate
(3 courses, 9 credits)
Boost your biotech industry knowledge and add a meaningful credential to your resume
Three 100% online courses give students a career edge in an increasing competitive workforce, and with just 9 credits, the certificate can be completed in just one year.
Biotechnology companies seek professionals who understand not only what they do, but—more importantly—how and why their work fits into a company’s global strategy for product development, manufacturing, and marketing.
This capstone certificate builds that understanding by highlighting how and why quality assurance and regulatory affairs are essential drivers of successful teams and product launches.
Students develop practical, professional skills in quality assurance and regulatory affairs required for working effectively within cross-functional teams and with government agencies.
Developed in collaboration with biotechnology industry experts, the program uses real-world scenarios to prepare participants to investigate why problems occur and how to design effective strategies to resolve them.
Ready to Apply?
Certificate Overview
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.
- Complete three required courses in one year.
- Investigate real-world scenarios to formulate and implement new strategies.
- Interact directly with faculty, subject matter experts, and other students through optional virtual meetings.
- Cost: $1,000/credit ($9,000 total)
Distinguishing Features
Connect with instructors who are national experts from private industry.
Meet virtually in real-time to interact with faculty and other students.
Employer tuition reimbursement possibly covers all three courses.
How You Learn
Fully online curriculum with collaborative online coursework; you choose when you do most of your work each week.- Case study format allows you to develop critical thinking and communication skills while learning to negotiate aspects of product development, from pre-submission to product launch with colleagues, customers and local, state and federal agencies.
- Explore case studies with industry experts during virtual meeting opportunities (also available recorded).
- Develop knowledge and awareness by interacting with a community of experienced professionals.
Fully online curriculum with collaborative online coursework; you choose when you do most of your work each week.Course Curriculum & Faculty
Course Curriculum
- biomdsci 720: Survey of Quality Assurance and Regulatory Affairs in Biotechnology (3 credits)
Success in the biotechnology industry is based on learning the language and understanding the development process utilized in bringing products to market. Focus on techniques used in the biotechnology industry to comply with the quality and regulatory requirements set forth by professional and governmental agencies in the effort to develop, manufacture, and commercialize products safely for the public.- Next Offering: Fall 2026 (first step, apply for admission to the certificate)
- biomdsci 721: Drugs & Biologics: Topics in Quality Assurance and Regulatory Affairs in Biotechnology (3 credits)
Quality Assurance and Regulatory Affairs departments influence and facilitate successful product development within the biotechnology industry. Use a case study approach to explore and apply how quality assurance and regulatory compliance systems are used to bring drugs and biologics to market. Practice how cross functional teams work together to meet regulatory standards of safety. - biomdsci 722: Leadership in Quality Assurance and Regulatory Affairs in Biotechnology (3 credits)
Leaders in the Quality Assurance and Regulatory Affairs departments influence and facilitate bringing products to market within the biotechnology industry. Focus on building communication among cross functional teams; exercising writing to specific audiences; and meeting internal and external customer needs and expectations. Explore and apply how quality and regulatory affairs skills are managed within diverse product and project teams.
Natalie Betz
Credentials: PhD in Biochemistry and Molecular Biology
Position title: Academic Director
M.S. in Biotechnology Program (in-person)
Capstone Certificate in Quality Assurance & Regulatory Affairs (online)
School of Medicine and Public Health
University of Wisconsin - Madison
Linda Miller
Credentials: MS in Biotechnology
Position title: Senior Project Manager, Product and Portfolio Strategy, Novocure
Adjunct Professor, UW-Madison School of Medicine and Public Health
Kashif Sheikh
Credentials: MS, ASQ-CAQ
Position title: Consultant
Adjunct Professor, UW-Madison School of Medicine and Public Health
How to Apply
Admission Requirements
All applicants must have:
- A bachelor’s degree from an accredited institution.
- A minimum undergraduate GPA of 3.0.
- Completed one general biology course with a laboratory at the undergraduate level.
- If applicable, evidence of English language proficiency. The required proficiency scores are: TOEFL IBT 92, PBT 580; or IELTS 7.0.
Application materials required:
- Online application (with the Division of Continuing Studies)
- Professional resume
- Statement of purpose
- Undergraduate transcript (unofficial copy accepted)
- Two letters of recommendation
Have Questions?
Contact Michele Smith
Michele Smith, MS, SCT (ASCP) is our Graduate Program Manager leading the QA/RA Capstone Certificate. She is the ideal person to answer any questions you have about the QA/RA certificate.
Michele Smith
Credentials: M.S. in Biotechnology, SCT (ASCP)
Position title: Graduate Program Manager
M.S. in Biotechnology Program (in-person)
Capstone Certificate in Quality Assurance & Regulatory Affairs (online)
School of Medicine and Public Health
University of Wisconsin - Madison
Email:
michele.smith
Phone: Office: (608) 262-9870