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Program Policies and Resources
Substitutions, Waivers, and Transfer Credit
Curriculum and Completion Requirements
Courses Available in
- Health Professions Preparation
- Biology
- Advanced Bioscience
- Chemistry and Green Chemistry
- Physics
- Geology and Environmental Sciences
- Biotechnology and Bioscience Business
- Clinical and Regulatory Sciences
- Development and Manufacturing
- Project Management for Biopharmaceuticals
- Mathematics and Statistics
Victoria Sharma
Program Director
Quality and Compliance for Biotechnology
View the BrochureEDP 402363
Build a thorough foundation in the skills and knowledge needed to perform and oversee quality and regulatory compliance functions within the biotechnology industry. In the rapidly growing field of compliance, regulations and guidelines govern the research, development, manufacture and clinical trials process, as well as the marketing and sales of drugs, biologics and medical devices. The Professional Program in Quality and Compliance for Biotechnology reviews Good Pharmaceutical Practice (GXP) principles, procedural guidelines, FDA and other regulations and ethical considerations. The comprehensive program prepares you for a career in quality assurance, quality control or compliance. The curriculum includes electives drawn from the related functional areas of clinical research, product and process development, manufacturing and supply chain, and regulatory affairs. Many of the required and elective courses apply to multiple programs, allowing you to earn credit while you find the curriculum that's right for you. Join our email list to stay informed about this program.
Courses
The table contains the required courses for the Professional Program in Quality and Compliance for Biotechnology, as well as the terms they are typically available for enrollment.
6 Required Courses, 2 Electives, 10 Semester Units (150 Hours of Instruction)
| Required Courses | Course Number | Units/ CEU | Classroom | Online |
|---|---|---|---|---|
| Principles of Quality and Compliance | X401.6 | 1 | Fall Spring Summer |
|
| Good Clinical Practices (GCP): Drugs and Biologics | X475.3 | 2 | Fall Spring |
|
| Good Manufacturing Practices (GMP): Quality Assurance (QA) in Practice | X401.4 | 2 | Summer | |
| Good Manufacturing Practices (GMP): Quality Control (QC) in Quality and Compliance | X401.7 | 1 | Spring | |
| Inspections and Audits for Quality and Compliance | X401.5 | 1 | Fall | |
| Validation and Interfacing with Quality Assurance (QA) | X401.8 | 1 | Spring |
| Electives | Course Number | Units/ CEU | Classroom | Online |
|---|---|---|---|---|
| CMC Regulatory Compliance for Pharmaceutical Products | X401.1 | 2 | Fall Spring |
|
| Introduction to Clinical Research: Clinical Trial Phases and Design | X400.2 | 3 | Fall Spring |
Fall Spring Summer |
| Principles of Supply Chain and Manufacturing | X475.7 | 1 | Fall Spring Summer |
|
| Principles of Product and Process Development | X431 | 1 | Spring | |
| Principles of Regulatory Affairs | X401.3 | 1 | Fall Spring Summer |
Course availability is subject to change. Courses offered in both online and classroom environments are interchangeable, and you may choose either format.
To enroll, click on a course title above and choose a section.
You may enroll in individual courses without registering for the Professional Program in Quality and Compliance for Biotechnology.
Who Will Benefit
If you are currently in the biotechnology industry and hold a baccalaureate or graduate-level degree—or if you have a scientific background and wish to change fields—this program is ideal. The program is also a fit if you are a professional already working in the various functional areas in biotechnology and pharmaceutical companies, contract research and manufacturing organizations.
Prerequisites for Admission
One year of college-level chemistry, biology or engineering is required for the Professional Program in Quality and Compliance for Biotechnology.
Curriculum Requirements
This program comprises 6 required courses and a minimum of 2 electives for a total of 10 semester units (150 hours of instruction). Because the discipline requires broad understanding of various aspects of the industry, the electives include courses from related and interfacing disciplines. Candidates must pay a nonrefundable program registration fee.
All coursework must be completed within five years of registering for the program. However, requirements may be updated based on new developments in the field of study; we recommend completing the curriculum in a timely fashion. For more information, please see the completion requirements and the substitutions, waivers and transfer credit policies.
How to Register for This Specialized Program of Study
By registering, you declare your intention to complete the curriculum. To register for the Professional Program in Quality and Compliance for Biotechnology, submit the online registration form with your credit card information or complete the mail-in registration form. The registration fee is nonrefundable.
Estimated Cost
Each course is priced individually, and you pay the course fee at the time of enrollment. The program has an estimated cost of $5,085 (not including course materials or registration fee). Course fees are subject to change.
Contact Information
To contact the department office, email science@unex.berkeley.edu or call (510) 642-1062.
Advisory Board
Peter Calcott, Ph.D.
President
Calcott Consulting
Bonnie Miller, M.S., RN
President
BMQCR, Bonnie Miller Quality Clinical Research Consulting LLC
Liz Wool, B.S.N., CCRA, CMT
President and CEO
QD-Quality and Training Solutions Inc.
Board of Trustees
Association of Clinical Research Professionals (ACRP)
Editorial Advisory Board
ACRP Monitor magazine
President, Northern California Chapter
ACRP
Linda Yang, Ph.D., M.B.A., RAC
Director, Analytical Development
Adams Pharmaceutical Inc.
