Regulatory Affairs
Certificate Program

Regulatory Affairs

Guiding the discovery journey

Enroll in Certificate View Individual Courses

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. Total of Six Required Courses. Also, choose 1 course each from A, B and C.
Interacting with the FDA 1.5
Regulation of Drugs and Biologics 3.0
Regulation of Medical Devices and Diagnostics 3.0
2. Required Course (A) Choose 1 of the 2 courses
Design Control for Medical Devices 2.0 + +
Drug Development Process 3.0
3. Required Course (B) Choose 1 of the 2 courses
Regulatory Submissions: Devices and Diagnostics 2.5
Regulatory Submissions: Drugs and Biologics 2.0
4. Required Course (C) Choose 1 of the 2 courses
Good Manufacturing Practices 3.0
Quality Systems for Medical Devices: FDA QSR and ISO 13485 2.5
5. Five Elective Course Units Required
Global Medical Device Submissions and Strategy 1.5
Good Clinical Practices 3.0
ICH Quality Guidelines: Intent and Overview 2.0
Post-Market Regulatory Obligations for Medical Devices 1.5
Preparing for FDA Inspections and Conducting Sponsor Audits 1.5
Risk Management for Regulated Industries 3.0
Validating Software for Medical Devices and Emerging Technologies 2.0
Value-Added Quality Audits 1.5
6. Additional Courses of Interest
Clinical Trials Essentials: An Intensive One-Week Course 3.5
Data Privacy and Security for Healthcare and Biosciences 1.5
7: Fee for Certificate Review
Regulatory Affairs Certificate Completion Fee None

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.

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

Kiran Gulati, 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-TUTTLEBA, 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 MAHARAJHMS, BS
Director, R&D
Carl Zeiss Meditec, Inc.

JENNIFER MASCIOLI-TUDOR, MBA, BS
Vice President, Quality Assurance & Regulatory Affairs
Outset Medical, Inc.

Certificate Inquiry Form

Contact Us
Speak to a student services representative.

Call (408) 861-3860

Envelope extension@ucsc.edu

Our recent stories on Regulatory Affairs