It is recommended that students take no more than two online courses at any one time. Students will not receive refunds for dropped courses.

BQS 601. Introduction to Biomedical Quality Systems (3 units)

• Course covers the origins, history of quality and the major concepts, theories, principles and founders; quality planning, assurance and improvement; the roles and responsibilities of quality assurance and quality control.

BQS 603. Foundational Quality Systems (3 units)

• Course covers the seven major global Foundational Quality Systems (FQS) on which other Biomedical Quality Systems are based. Students will learn the legal basis and support for these FQS, their current impact on the worldwide biomedical industry, and their overall influence on biomedical business.

BQS 620. Quality Control Methods Development (3 units) Prerequisite: BQS 601

• Strategies and approaches for development of quality control methods for characterizing drugs and biologics. Particular emphasis placed on development of HPLC methods.

BQS 621. Quality Audits – Internal, Vendors, and Contract Services (3 Units)
Prerequisite: BQS 601

• Approaches for systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.

BQS 696. Advanced Topics in Quality Assurance and Quality Control (1-4)
Prerequisite: BQS 601

• Current issues and topics in quality systems evaluated and discussed.  Recent developments and changes in selected areas of quality systems presented by faculty and industry professionals.  May be repeated with new content.  Maximum credit six units applicable to the Master of Science degree in Biomedical Quality Systems

BQS 730. Introduction to Good Manufacturing, Laboratory and Clinical Practices (3 units)
Prerequisite: BQS 601

• Review of good manufacturing practices and good clinical practices from a quality control and quality assurance perspective.

BQS 740. Statistical Process Control (3 units)
Prerequisite: BQS 601

• A basic course in statistical methods for quality control and improvement, focusing on control charts, measurement systems analysis, and process capability assessment.

BQS 741. Statistical Experimental Design (3 units)
Prerequisite: BQS 601

• Effective experimental strategy, factorial and fractional factorial designs, experiments with random factors, nested effects, categorical factors, and split plots. The use of computer software for design construction and analysis is integrated into the course. Examples from a wide range of process/product development and design settings are presented.

BQS 745. The Document Control Quality System (3 units)
Prerequisite: BQS 601

• A thorough examination and review of the document control quality system and the data, documents, information, and records that are mandated by the regulations. Included are consideration of standard operating procedures, laboratory equipment maintenance and calibration programs, documentation of laboratory results, and out-of-specification test results.

BQS 746. Quality Control Laboratory Validation (3 units)
Prerequisite: BQS 601

• Develop practical understanding for compliance with laboratory GMP requirements. Methods and strategies for validation of laboratory analytical procedures. Review of laboratory record keeping requirements.

BQS 750. Quality Improvement Management: Change Management and Continuous Improvement (3 units)
Prerequisite: BQS 601

• Covers all aspects of controlling and facilitating change at all levels within all types of companies. Takes the traditional quality tools, concepts and process improvement methods and applies them to the biotechnology industry. Students learn how to create strong relationships with upper management and peers, learning how to communicate expected financial returns resulting from a quality initiative, and how to sell benefits of those initiatives in a consultative manner.

BQS 797. Research (1-3 units)
Prerequisite: Consent of the instructor

• Research in the area of quality systems.  Maximum credit six units to a master's degree.

BQS 798. Special Study (1-3 units)
Prerequisite: Consent of the instructor

• Individual study.  Maximum credit six units applicable to a master's degree.

BQS 799A. Thesis or Project (3 units)
Prerequisite: An officially appointed thesis committee and advancement to candidacy

• Preparation of thesis or project for the Master's degree.

BQS 799B. Thesis or Research Project (0 units)
Prerequisite: Prior registration in Thesis 799A with an assigned grade symbol of SP.

• Registration required in any semester or term following assignment of SP in Course 799A in which the student expects to use the facilities and resources of the university; also students must be registered in the course when the completed thesis or project is granted final approval