Regulatory Affairs
Guiding the discovery journey
Certificate Description
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
Cost: $8,000
Required Credits: 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.
Duration: A full-time student can complete the certificate in 9–12 months.
Courses
| Course | Units | Fall | Winter | Spring | Summer |
|---|---|---|---|---|---|
| 1. Required Courses | |||||
| Interacting with the FDA | 1.5 | Fall Classroom | |||
| Regulation of Drugs and Biologics | 3.0 | Fall Classroom | Spring Classroom | ||
| Regulation of Medical Devices and Diagnostics | 3.0 | Winter Classroom | Summer Classroom | ||
| 2. Required Track (A); Choose 1 of the 2 courses | |||||
| Design Control for Medical Devices | 2.0 | + Fall Blended | + Spring Blended | ||
| Principles of Drug Discovery and Development | 4.0 | Fall Classroom | Winter Classroom | Spring Classroom | Summer Classroom |
| 3. Required Track (B); Choose 1 of the 2 courses | |||||
| Regulatory Submissions: Devices and Diagnostics | 2.5 | Fall Classroom | |||
| Regulatory Submissions: Drugs and Biologics | 2.0 | Summer Classroom | |||
| 4. Required Track (C); Choose 1 of the 2 courses | |||||
| Good Manufacturing Practices | 3.0 | Winter Classroom | Summer Classroom | ||
| Quality Systems for Medical Devices: FDA QSR and ISO 13485 | 2.5 | Fall Classroom | Spring Classroom | ||
| 5. Elective Courses (choose 2-4 courses to bring total program units to 19) | |||||
| European Medical Device Regulation | 3.0 | Fall Classroom | |||
| Global Medical Device Submissions and Strategy | 1.5 | Spring Classroom | |||
| Good Clinical Practices | 3.0 | Fall Classroom | Spring Classroom | ||
| ICH Quality Guidelines: Intent and Overview | 2.0 | Spring Classroom | |||
| Post-Market Regulatory Obligations for Medical Devices | 1.5 | Fall Online | |||
| Preparing for FDA Inspections and Conducting Sponsor Audits | 1.5 | Spring Classroom | |||
| Risk Management for Regulated Industries | 3.0 | Fall Classroom | |||
| Validating Software for Medical Devices and Emerging Technologies | 2.0 | Winter Classroom | |||
| Value-Added Quality Audits | 1.5 | Spring Classroom | |||
| 6. Additional Courses of Interest | |||||
| Clinical Trials Essentials: An Intensive One-Week Course | 3.5 | Winter Classroom | |||
| Data Privacy and Security for Healthcare and Biosciences | 1.5 | Summer Classroom | |||
| 7: Fee for Certificate Review | |||||
| Regulatory Affairs Certificate Completion Fee | None | Fall Online | Winter Online | Spring Online | Summer Online |
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
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
Dual Certification & Shared Credit
Learn more for Less: You can complete two bioscience certificate programs at UCSC Extension simultaneously or in sequence with fewer units than if the programs were taken individually. Students pursing two certificates need to:
- Complete the total number of units indicated in the table below.
- Complete all required courses for both programs.
- Count each unit only once.
- Select some electives that are common to both programs.
| Biotechnology | Clinical Trials | Medical Devices | Regulatory Affairs | Bioinformatics | |
|---|---|---|---|---|---|
| Biotechnology | 19 units | 32 units | 31 units | 32 units | 30 units |
| Clinical Trials | 32 units | 19 units | 31 units | 32 units | X |
| Medical Devices | 31 units | 31 units | 17 units | 31 units | X |
| Regulatory Affairs | 32 units | 32 units | 31 units | 19 units | X |
| Bioinformatics | 30 units | X | X | X | 16 units |
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.
Regulatory Affairs Certification
Helps prepare professionals with three to five 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
Certificate 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.
Certificate Program Advisory Committee
MEREDITH BROWN-TUTTLE, BA, RAC, FRAPS
Regulatory Affairs Consultant
Regulatorium
Author, Instructor
KIRAN GULATI, RAB-LA, M.B.A.,
Principal Medical Device Consultant/Exemplar Medical Device Lead Auditor
Kiran Gulati & Associates
Program Chair, Regulatory Affairs, UCSC Silicon Valley Extension
Program Chair, Medical Devices, UCSC Silicon Valley Extension
NANCY E. ISAAC, JD, MPH
Regulatory Counsel and VP Quality
Moximed, Inc.
NIRANJAN MAHARAJH, MS, BS
Director, R&D
Carl Zeiss Meditec, Inc.
JENNIFER MASCIOLI-TUDOR, MBA, BS
Vice President, Quality Assurance & Regulatory Affairs
Outset Medical, Inc.
