Quality Systems for Medical Devices: FDA QSR and ISO 13485


Through a series of lectures, interactive discussions and case studies, this course provides in-depth exposure to the fundamental concepts and major issues central to regulatory compliance in the medical device sector. The course emphasizes using the principles of the medical device quality system (QS) regulations and ISO 13485 as tools to take a process-oriented, risk-based approach to compliance, while achieving strategic business objectives in today's dynamic regulatory environment.

Prerequisites:


No prerequisites


Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
MEDD.X407.(2) 4/2/2018 06:15 PM SANTA CLARA 800 Kiran Gulati View Enroll

Drug Quality Fundamentals: Quality Control of Small Molecule Drugs and Biologics


This introductory course provides an overview of key drug quality concepts and standards for the pharmaceutical and biotechnology industries. Interactive lectures explore quality system and control process best practices in clinical development, drug manufacturing and for commercial products. You'll learn the roles and responsibilities of quality assurance (QA) and quality control (QC) in ensuring the safety, efficacy and quality of drug products. You'll contrast specific quality attributes of large-molecule recombinant biological products with those of small molecule drugs.

Prerequisites:


Offering code Offering title
BTEC.X401 Drug Development Process
REGL.X400 Good Manufacturing Practices
REGL.X403 Regulation of Drugs and Biologics

Bioscience Program Information and Q&A Session


This free evening event is an informal discussion geared towards new or returning students interested in one or more of the Bioscience certificate programs -- Biotechnology, Bioinformatics, Clinical Trials Design and Management, Regulatory Affairs, and Medical Devices. The event begins with a short overview of the five Bioscience certificates, followed by an open-floor segment for audience questions.

Prerequisites:


No prerequisites


Clinical Trials, Regulatory Affairs, and Medical Device Information Session


Are you interested in learning about the Clinical Trials, Regulatory Affairs, and Medical Device certificate programs, and about careers in these fields?
This special information session provides an opportunity to meet instructors and other students, learn about program prerequisites, program philosophy, course content and program requirements, and gain insights into careers in clinical research, regulatory affairs, and medical devices.

Prerequisites:


No prerequisites


Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
16650.(026) 1/9/2018 06:30 PM SANTA CLARA 0 View Enroll

Regulatory Affairs Certificate Completion Review


Once all of the certificate requirements have been met and your final grades are posted, please access your Student Portal to enroll in the “Certificate Completion Review” to begin the review process. Please allow up to 4 weeks to receive your certificate.

Prerequisites:


No prerequisites


Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
O-CE0364.(008) // 04:00 PM 75 View Enroll
Regulatory Affairs

Group

About

Regulate the Positive

How do bioscience professionals ensure that new products are safe and effective?

Before a new medical device, drug, biologic or diagnostic is introduced to the public, it must meet minimum regulatory requirements. Regulatory affairs professionals ensure compliance with the laws and regulations guiding the development and commercialization of healthcare products. Our Regulatory Affairs certificate will familiarize you with the fundamentals of drug development, new product documentation, and ethical and management competencies needed to succeed in this field.

Pick up skills course by course or declare candidacy for the certificate to add a UC credential to your resume.

FDA: What You Need to Know

Unsure how to respond to FDA audits and requirements? Our courses detail the legal processes and procedures regulatory personnel need to know to help get a drug to market.

Global Outlook

Regulations vary from country to country. Our curriculum offers practical insight on navigating regulations in the US and around the world.

Prepare for the RAC

Working toward Regulatory Affairs Certification? Prepare for this rigorous exam by immersing yourself in the certificate.

Earn Two Certificates For Less

Complete two Bioscience certificates, simultaneously or in sequence, with fewer units, by selecting shared electives. Contact us to get help creating a personalized study plan.

WHAT STUDENTS SAY

"The coursework was fantastic; it helped me prepare for the RAC exam." –Leena Kadakia

The Profession

Quality + Compliance = Success

Skilled regulatory affairs professionals are needed in a variety of settings, including:

  • Small, mid-size and multinational companies
  • Government agencies such as the US FDA or the European Medicines Agency
  • Clinics and hospitals
  • Universities invested in research and clinical trials
  • Consultancies
  • Clinical research operations (CROs)

While the scientific and regulatory background is critical, regardless of your position, as your career progresses it will be even more important to ensure that your knowledge of regulations is up-to-date—and that you are able to communicate changes clearly and effectively.

WHAT YOU CAN EXPECT

  • Average Earnings

In 2016, the Regulatory Affairs Professional Society surveyed 3,358 regulatory professionals around the world to inquire about compensation and experience. Among the findings, respondents reported an average increase of 5.9% in base compensation from 2014-15 levels. –2016 Scope of Practice & Compensation Report for the Regulatory Profession

  • Job Prospects

Regulatory affairs managers can expect a bright career outlook because they are projected to have 100,000 or more job openings by 2024. –O*Net OnLine

STUDENT SPOTLIGHT

“The program further enhanced the knowledge and skillset that I gained through on-the-job training as a regulatory affairs professional.” –April Raj

Outcomes

Program Objectives

As a graduate of the Regulatory Affairs certificate program, you’ll have the skills to:

  • 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

ACCORDING TO OUR STUDENTS

"The program definitely opened the door for me." –Shilpa Mydur

Curriculum

Program Format

UCSC Extension’s Regulatory Affairs courses are offered at UC Santa Cruz Silicon Valley Campus, a beautiful facility located on the corner of Scott and Bowers in Santa Clara. Many of our courses are available online. Choose courses according to your interest or declare candidacy in the certificate for a more comprehensive overview of the field.

Regulatory Affairs Courses

Total: 19 units

Required: 6 courses

Electives: 5 units required

To complete the certificate, you must complete a minimum of 19 units; 6 required courses and at least 5 units of elective courses.

Required Courses:

All of the following:

  • Regulation of Drugs and Biologics, 3 units
  • Regulation of Medical Devices and Diagnostics, 3 units
  • Interacting with the FDA, 1.5 units

One of the following:

  • Drug Development Process, 3 units  OR
  • Design Control for Medical Devices, 2 units

One of the following:

  • Regulatory Submissions: Drugs and Biologics, 2 units  OR
  • Regulatory Submissions: Devices and Diagnostics, 2.5 units

One of the following:

  • Good Manufacturing Practices, 3 units  OR
  • Quality Systems for Medical Devices FDA QSR and ISO 13485, 2.5 units

Electives:

5 units required

  • Design Control for Medical Devices, 2 units
  • Drug Quality Fundamentals: Quality Control of Small Molecule Drugs and Biologics, 1.5 units
  • Global Medical Device Submissions and Strategy, 1.5 units
  • Good Clinical Practices, 3 units
  • Medical Device Marketing, 3 units
  • Mobile Health: The Evolving Industry and Regulatory Landscape, 1 unit
  • Post-Market Regulatory Obligations for Medical Devices, 1.5 units
  • Preparing for FDA Inspections and Conducting Sponsor Audits, 1.5 units
  • Regulation of in vitro Diagnostics in Europe and the U.S., 2.5 units
  • Risk Management for Regulated Industries, 3 units
  • Validating Software for Medical Devices and Emerging Technologies, 2 units
  • Value-Added Quality Audits, 1.5 units

Also Recommended

  • Data Privacy and Security for Healthcare and Biosciences, 1.5 units

Also of Interest

  • Clinical Trials Essentials: An Intensive One-Week Course, 3.5 CEUs

Prerequisites

Given the scientific foundations of the bioscience industry and the importance of effective communication to the regulatory role, students who come to the program 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

We recommend students begin the program with “Quality Systems for Medical Devices FDA QSR and ISO 13485" (formerly titled "Medical Device Quality Systems”) or “Good Manufacturing Practices,” followed by “Drug Development Process” or “Regulation of Medical Devices and Diagnostics.”

Any one course from UCSC Extension's Clinical Trials Design and Management or Medical Devices Certificate Programs may be applied toward the elective unit requirement for the Regulatory Affairs Certificate.

INFO SESSIONS

Want to learn more about our curriculum in person? Join us for a free Info Session to learn more about our courses, faculty, and program requirements. Learn more on our Events page.

PRICE

The rough cost of the Regulatory Affairs certificate is estimated at $8,000.

Enroll

Enrollment

No application is required to enroll in our courses or certificate programs. Information about our open enrollment process can be found on our Enrollment page. If you have any questions about our programs, please contact the UCSC Extension Outreach office by phone at 408-861-3860, or by email at extensionprogram@ucsc.edu.

From the schedule below, click on a course title to see sections available for enrollment. You may view the full course schedule, or enroll in the course, by clicking the respective button. The course type offerings (classroom, online, blended) are guidelines and subject to change. A blended (hybrid) course has both classroom and online components.

Declaring Candidacy

If you intend to pursue a certificate, declaring candidacy establishes program requirements early in your studies, so any subsequent curriculum changes do not affect your progress. It does not limit what courses you can take; and it helps you structure your professional development program for maximum benefit to you. Go the declare candidacy page to establish your requirements for this program. Certificate program requirements must be completed within three years of declaring candidacy.

Course Schedule


1. Total of Six Required Courses.
classroom : Classroom
online : Online
hybrid : Blended
Classroom and Blended : Classroom and Blended
Classroom and Online : Classroom and Online
Online and Blended : Online and Blended
Offering Code Offering Units Fall Winter Spring Summer
REGL.X403 Regulation of Drugs and Biologics 3.0 Classroom Classroom
REGL.X404 Regulation of Medical Devices and Diagnostics 3.0 Classroom Classroom
REGL.X402 Interacting with the FDA 1.5 Classroom Classroom
2. Required Course (A) Choose 1 of the 2 courses
classroom : Classroom
online : Online
hybrid : Blended
Classroom and Blended : Classroom and Blended
Classroom and Online : Classroom and Online
Online and Blended : Online and Blended
Offering Code Offering Units Fall Winter Spring Summer
BTEC.X401 Drug Development Process 3.0 Classroom Classroom Classroom
MEDD.X400 Design Control for Medical Devices 2.0 Blended
3. Required Course (B) Choose 1 of the 2 courses
classroom : Classroom
online : Online
hybrid : Blended
Classroom and Blended : Classroom and Blended
Classroom and Online : Classroom and Online
Online and Blended : Online and Blended
Offering Code Offering Units Fall Winter Spring Summer
REGL.X405 Regulatory Submissions: Devices and Diagnostics 2.5 Classroom
REGL.X406 Regulatory Submissions: Drugs and Biologics 2.0 Classroom
4. Required Course (C) Choose 1 of the 2 courses
classroom : Classroom
online : Online
hybrid : Blended
Classroom and Blended : Classroom and Blended
Classroom and Online : Classroom and Online
Online and Blended : Online and Blended
Offering Code Offering Units Fall Winter Spring Summer
REGL.X400 Good Manufacturing Practices 3.0 Classroom Classroom
MEDD.X407 Quality Systems for Medical Devices: FDA QSR and ISO 13485 2.5 Classroom Classroom
5. Elective Courses
6. Also of Interest
classroom : Classroom
online : Online
hybrid : Blended
Classroom and Blended : Classroom and Blended
Classroom and Online : Classroom and Online
Online and Blended : Online and Blended
Offering Code Offering Units Fall Winter Spring Summer
CTDM.X407 Data Privacy and Security for Healthcare and Biosciences 1.5 Classroom
CTDM.X801 Clinical Trials Essentials: An Intensive One-Week Course 3.5 Classroom
7: Required Certificate Review
classroom : Classroom
online : Online
hybrid : Blended
Classroom and Blended : Classroom and Blended
Classroom and Online : Classroom and Online
Online and Blended : Online and Blended
Offering Code Offering Units Fall Winter Spring Summer
O-CE0364 Regulatory Affairs Certificate Completion Review

Pages