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Quality Assurance & Control

Regulatory Affairs for the Biomedical Industry Certificate

Developed to educate professionals in the FDA imposed regulation issues pertinent to the pharmaceutical and biological industry, this certificate covers a broad range of necessary technical and business skills. It is designed for regulatory and quality professionals and those involved directly in drug development, including chemists, pharmacologists, and biologists. Issues that influence laboratory, clinical trials, manufacturing practices and procedures are discussed, and the fundamentals of bioethics provide a framework for ethical decisions. Our knowledgeable team of instructors includes executive level regulatory professionals, a previous FDA inspector, and consultants with up to 20 years experience in quality and compliance with U.S. FDA and ICH requirements. With this breadth and depth of experience, instructors expose students to many real workplace examples. This program, which grew from demands by local biotech professionals and the advisory board, offers a well-rounded curriculum and provides career growth and opportunities for students interested in the field of Regulatory Affairs. Program Benefits Professional certificate programs from the University of California have enjoyed increasing recognition among employers as evidence of academic advancement for post-baccalaureate professionals with a strong applied workplace focus. For those making career transitions, it offers university-accredited certification for the knowledge and skills acquired as part of this program. For those with significant experience in the field, but who do not have a primary degree, the professional certificate provides formal academic documentation of initiative and commitment to tackle and complete this type of advanced certified education program.

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Certificate Course Matrix
Course Title Course Number Units FA WI SP SU
REQUIRED COURSES (All eight are required)
Overview of the Drug Development Process
BIOL-40015
3
O O 
Regulatory Requirements for Drugs & Biologics
BIOL-40102
2.5
O O 
Good Manufacturing Practices
BIOL-40000
3
OOOO
Good Laboratory Practices
BIOL-40085
2
OO, X O
Regulatory Compliance for Drugs & Biologics
BIOL-40101
2
O, XOOO
Good Clinical Practices
FPM-40204
3
 S S
Introduction to Bioethics
BIOL-40071
2
  X 
Advanced Topics in Regulatory Affairs
BIOL-40110
3
 X  
ELECTIVES (Four units are required)
Analytical Chemistry
BIOL-40195
3
X   
Chemistry, Manufacturing and Controls
CHEM-40002
1
 O O
Good Documentation Practices
BIOL-40201
3
   X
Interest-Based Negotiation
BUSA-40128
3
L, OLLL
In Vitro Diagnostics Product Development
BIOL-40244
2
X X 
IT Management in FDA-Regulated Industries
BIOL-40217
2
Schedule Varies
Overview of Regulatory Affairs for Medical Device Professionals
BIOL-40080
2
   X
L=La Jolla M=Mission Valley O=Online R=Rancho Bernardo S=Sorrento Mesa X=Location TBA
Certificate Programs

To Register in the Certificate Program

Certificate registration is required to complete the program. Candidates are encouraged to register in the certificate program as early as possible to take advantage of program benefits. See Certificate FAQs for more information.

Certificate Section ID: 073923 Register Now!
Application Fee: $50
Contact: Life Sciences, (858) 882-8027
E-mail: unexbio3@ucsd.edu

Advisors

Ingrid Cabalza, RAC
Quality Assurance Associate
Gen-Probe, Inc.

Steve Kradjian, RAC
President and Chief Executive Officer
Conventus Biomedical Solutions, Inc.

Allen McCutchan, M.D.
Professor of Medicine, Division of Infectious Diseases
UCSD School of Medicine

Brian Miyazaki, RAC
Associate Director, Regulatory Affairs
Amylin Pharmaceuticals, Inc.

Kathy Rangus
President
Drug and Device Regulatory Services

Camille Shore, Ph.D.
Senior Manager, Regulatory CMC, Pharmaceutical Sciences
Pfizer, Inc.

Barbara-Helene Smith, Ph.D., RAC
Regulatory Affairs Certified Consultant