Online Capstone Certificate
(3 courses, 9 credits)
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 created 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.
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 two or three semesters. You may take more than one topic course, if available, based on your professional goals.
- 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 likely covers all three courses.
How You'll 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
- BIOMDSCI720: 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: Spring 2025 (first step, apply for admission to the certificate)
- BIOMDSCI721: 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.- Note: The Spring 2025 BIOMDSCI721 course will focus on drugs and biologics. As a “special topics” course, future BIOMDSCI721 offerings may address other biotechnology product categories, such as medical devices, diagnostic tests, and more.
- 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)
M.S. in Applied Biotechnology (online)
Capstone Certificate in Applied Bioinformatics
School of Medicine and Public Health
University of Wisconsin - Madison
Hansi Dean
Credentials: PhD
Position title: Vice President and Head of Discovery Research, Takeda Vaccine Business Unit
Adjunct Professor, UW-Madison School of Medicine and Public Health
Peter Green
Credentials: PhD, RAC (US)
Position title: Regulatory Manager, Hollister Incorporated
Adjunct Professor, UW-Madison School of Medicine and Public Health
Jennifer Leny
Credentials: MS in Biotechnology, MBA
Position title: Quality Assurance at WiCell
Adjunct Professor, UW-Madison School of Medicine and Public Health
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: Director of Quality Assurance, eGenesis, Inc.
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)
M.S. in Applied Biotechnology (online)
Capstone Certificate in Applied Bioinformatics
School of Medicine and Public Health
University of Wisconsin - Madison
Email:
michele.smith
Phone: Office: (608) 262-9870