Regulatory Affairs Certificate | UCSC Silicon Valley Extension

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Certificate Program
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 | International Tuition Cost

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	Summer
1. Required Courses
Interacting with the FDA	1.5
Regulation of Drugs and Biologics	3.0
Regulation of Medical Devices and Diagnostics	3.0
2. Required Track (A); Choose 1 of the 2 courses
Design Control for Medical Devices	2.0	+	+
Principles of Drug Discovery and Development	4.0
3. Required Track (B); Choose 1 of the 2 courses
Regulatory Submissions: Devices and Diagnostics	2.5
Regulatory Submissions: Drugs and Biologics	2.0
4. Required Track (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. Elective Courses (choose 2-4 courses to bring total program units to 19)
European Medical Device Regulation: Clinical Evaluation and Post-Market Surveillance	3.0
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
Regulation of in vitro Diagnostics in Europe and the US	2.5
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.

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 Principles of Drug Discovery and Development 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

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.

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 candidacy, you have five years to complete the program.

Enroll Now