Professional Program in Quality and Compliance for Biotechnology

Note: We currently are not accepting new certificate registrations for this program. Courses in the existing curriculum will continue to run as scheduled for a limited time, through spring semester 2017.

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.

Curriculum Requirements

This program comprises 5 required courses and 3–4 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.

You must take all courses for a letter grade. To receive the Award of Completion, you must maintain an overall minimum 2.5 grade point average, with a grade of C or better in each course. All coursework must be completed within five years of registering for the program.

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 $5,750 (not including course materials or registration fee). Course fees are subject to change.

Certificate and Award Request

Once you have completed the program coursework, notify UC Berkeley Extension that you have completed the curriculum and request your Award of Completion. Send an email to biotech_online@berkeley.edu or call (510) 642-1062. After your records have been reviewed, verified and approved, your award will be sent to you in the mail. The review of your records is usually completed within six to eight weeks after you request the award.

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.

Professional Program in Quality and Compliance for Biotechnology

Straight to your inbox each month: news and updates in

Thank you, and welcome to the UC Berkeley Extension community!

Email Privacy Policy

Ask a question about . We will email you a response shortly.