Life sciences industry professionals must be committed to repeatedly producing safe, effective and reliable products. The CSU offers a wide range of courses that can introduce students to the body of knowledge associated with the quality assurance. The American Society of Quality Biomedical Division 
provides training and education programs and networking opportunities to help professionals advance their careers.
The range and number of job openings for quality professionals in the life sciences industry can be discovered using typical web search tools.
The CSU quality assurance courses listed below have been developed for biotechnology industry practice and incorporate regulatory concepts and case studies.
BIOL 516 Clinical Trials and Quality Assurance (Online)
An introduction to the foundational knowledge and skills necessary to successfully conduct clinical trials for new drugs, biologics, and medical devices, including in vitro diagnostics. Topics include a broad overview of the product development process in the pharmaceutical, biopharmaceutical, and medical device industries, the regulatory and operational requirements for clinical study setup and management, monitoring, data management, and closure of clinical trials, the principles of Good Clinical Practice (GCP), and the applications of quality control and quality assurance. The integration of quality assurance throughout the medical product development process will be discussed.
For more information contact: exed@csuci.edu or click here .
QAS 511 Quality Function Management & TQM
This course provides a study of basic quality concepts as applied to organizational entities, with specific emphasis on the unique requirements of the biotech industry. TQM concepts, quality function deployment, and the tools for continuous improvement are analyzed for application and deployment in both biotech laboratory development and biotech manufacturing. Theories and methodologies examined in this course will assist these types of companies in achieving organizational excellence through continuous improvement.
For more information or to apply click here.
QAS 539 Good Manufacturing Practices
This course examines FDA Good Manufacturing Practice regulations as applied to medical device, pharmaceutical production, and laboratory development. Device design covers development, manufacturing, quality records, management and organizational requirements as related to quality assurance methodologies. Pharmaceutical production and laboratory development include personnel, facilities and equipment, process and product controls, laboratory, reporting using the fundamentals of quality assurance methodologies as related to the biotech industry.
For more information or to apply click here.
QAS 541 Biomedical Quality Control Methods
In depth study of quality control disciplines as applied to medical device, pharmaceutical and/or biologics regulated environments. Topics include influencing discipline and applying models; methods that monitor, maintain and/or improve product or service quality; operational efficiency.
For more information or to apply click here .
QAS 542 Risk Management in FDA Regulated Agencies
Risk Management as applied to FDA-regulated and other industries (product and process-related); emphasizes application of risk management tools, plan and program from inception of product and process until and including manufacturing process and field experience of the product , process or service.
For more information or to apply click here .
BIOL 7705 Good Manufacturing Practices
This course reviews current Good Manufacturing Practice regulations to assure quality of marketed products. Application to manufacturer's organization, personnel, facilities, equipment, control systems, production, process controls, laboratory procedures and records are all covered.
For more information or to apply click here .
RA 770 Current Good Manufacturing Practice
Current Good Manufacturing Practice regulations to assure quality of marketed products. Application to manufacturer's organization, personnel, facilities, equipment, control systems, production, process controls, laboratory procedures and records. (Offered only as a distance education course)
For more information call (619) 594-6030 or click here .
Quality Compliance GXP
This is a survey of quality standards that biotechnology, pharmaceutical, and device companies must adhere to when conducting clinical trials. Quality standards include Good Manufacturing Practice (GMP) or Quality Systems Regulation (QSR), Good Laboratory Practice (GLP), ISO 9000, and medical device regulatory standards.
For more information contact: Program Director at (415) 817-4226 or click here .
General Lean and Six Sigma Courses
Lean and Six Sigma are approaches that are commonly used in heavy manufacturing industries to improve operational efficiencies, but have been adapted and deployed by many biotech and pharmaceutical companies today. The CSU courses listed below provide students with training in six sigma concepts. To see a listing of job opportunities in the life sciences in these areas click here.
SECS 5016 Six Sigma Black Belt, Advanced Statistical Techniques and Processes
Black Belts play a vital role within a Six Sigma initiative as they learn to supervise the Green Belts efforts of data collection and analysis and process mapping. This course will provide students with advanced tools and approaches to further enhance the process of using the DMAIC methodology. Student project presentation to the entire class will be re-evaluated using the additional techniques learned during this course.
For more information or to apply click here .
Six Sigma: Total Quality Applications
Learn how to effectively apply the elements and methods of Six Sigma. This course will help you prepare for the internationally-recognized Six Sigma Black Belt and Quality Manager exams offered by the American Society for Quality® (ASQ®).
For more information or to apply click here .
Six Sigma Black Belt
The Black Belt training program integrates online learning with hands-on data analysis. The course material provides an in-depth look at the DMAIC problem-solving methodology, as well as deployment and project development approaches. The course flow follows the DMAIC methodology, with the appropriate tools and concepts taught at each stage of project deployment. Since software will be used for data analysis, the course material concentrates on the application and use of the tools, rather than on detailed derivation of the statistical methods. Workshops are incorporated extensively throughout the training to challenge the student’s analytical and problem-solving skills.
For more information or to apply click here .
Six Sigma Green Belt
Six Sigma Greenbelt is a Quality Improvement methodology structured to reduce product or service failure rates. This online program encompasses all aspects of a business, including management, service delivery, design, production and customer satisfaction. Six Sigma is one of the highest standards for companies and individuals to achieve. This interactive online experience provides the skills needed to affect this highly valuable skill as well as prep for the national certification. All materials are included.
For more information or to apply click here .
