Regulatory Affairs
Guiding the discovery journeyProgram Description
Classroom • Online • Blended
Navigate the complex regulatory world of medical discovery and commercialization. Students learn the journey of safe and ethical medical device and drug development. You will identify the critical roles in the industry, best practices for product documentation and risk management. Learn industry requirements, federal regulations and audits and global standards. Network with people in the industry.
Regulatory Affairs certificate program objectives:
- Provide regulatory submissions of drugs and biologics
- Differentiate the roles and responsibilities between quality assurance (QA) and quality control (QC)
- Understand and apply GXPS (Good Manufacturing Practices (GMPS)/Quality System Regulation) for drugs/biologics/medical devices.
- Apply risk management principles to products, processes and services within biomedical industries
- Set up and implement medical device verification and validation programs
Curriculum: Total Required: 8–10 courses/19 units. Take 6 core courses (3 designated, plus one each from three categories) (13.5–15.5 units) and 2–4 elective credit courses (5 units). End with certificate of completion review.
Time Commitment: A full-time student can complete the certificate in 9–12 months.
Estimated Cost: $8,000
Cost for F1 Students: [Costs for F-1 students]
Courses
Curriculum: Total Required: 8–10 courses/19 units. Take 6 core courses (3 designated, plus one each from three categories) (13.5–15.5 units) and 2–4 elective credit courses (5 units). End with certificate of completion review.
Total of Six Required Courses.
Required Course (A) Choose 1 of the 2 courses
Required Course (B) Choose 1 of the 2 courses
Required Course (C) Choose 1 of the 2 courses
Elective Courses
Required Certificate Review
Requisite Knowledge
Please review the course descriptions to ensure that you have taken necessary prerequisites or meet the requirements through job experience or previous education. Students with a basic understanding of the life sciences and strong written and oral communication skills will gain the most from this program.
Recommended Course Sequence
Please follow this sequence:
Begin with Quality Systems for Medical Devices FDA QSR and ISO 13485 (formerly Medical Device Quality Systems) or Good Manufacturing Practices, followed by Drug Development Process or Regulation of Medical Devices and Diagnostics. After that, courses may be taken in any order provided the prerequisites are met.
Substitutions: You may take one elective outside the certificate curriculum, if you receive prior approval from the Academic Services Department.
Dual Certification & Shared Credit. Earn two bioscience certificates with fewer units by selecting shared electives. Any one BIoscience course may be applied toward the elective unit requirement for the this certificate program. Contact Program Outreach to get help creating a personalized study plan.
To receive your certificate. Upon completion of the course sequence you may request your Regulatory Affairs Certificate Completion Review.
Also recommended:
Data Privacy and Security for Healthcare and Biosciences, 1.5 units
Clinical Trials Essentials: An Intensive One-Week Course, 3.5 units
Professional Development
Dual Certification & Shared Credit. Earn two bioscience certificates with fewer units by selecting shared electives. Any one course from the Biotechnology certificate program may be applied toward the elective unit requirement for any other biosciences certificate program. Contact Program Outreach to get help creating a personalized study plan.
Regulatory Affairs Certification. Helps prepare professionals with 3–5 years in the regulatory field for the Regulatory Affairs Certification (RAC) exam, the only post-academic professional credential for regulatory professionals in the healthcare product sector.
Program Chair
KIRAN GULATI, RAB-LA, M.B.A., is a management consultant with more than 25 years' experience in quality systems and process improvement for the medical device and biotech sectors. She has held positions at Genentech and McGhan Medical (formerly Collagen Corporation), where she managed the auditing and quality system training functions and has extensive experience designing and training for companies in domestic and international settings. Since 2001, she has helped medical device startups and established companies achieve successful results during ISO 13485, CE Mark assessments, and FDA audits. Gulati has served as chair of RAPS San Francisco Bay Area chapter and is currently on the RAPS North American Advisory Board. She has been a speaker at conferences sponsored by the Institute of Validation Technology (IVT) and the ASQ Silicon Valley Division. She has taught for UCSC Extension since 2006 and serves on the advisory boards for the UCSC Extension Medical Devices and Regulatory Affairs certificate programs.
Enroll in Program
You are invited to declare candidacy in your certificate program as soon as possible so you can lock in the curriculum requirements and not be impacted by any subsequent program changes. Once you’ve declared, you have three years to complete the program.
Contact
Have a question about Regulatory Affairs Certificate Program or want to subscribe for updates? Use the form below.
You may also contact our Outreach Team at (408) 861-3860 or ExtensionProgram@ucsc.edu.
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