Required courses:

Four courses are required for the Advanced Certificate in Biomedical Quality Systems. Note that as of September 1, 2007, either BQS 603 or BQS 621 may be taken to satisfy certificate requirements.

BQS 601. Introduction to Biomedical Quality Systems (3 units)
Course covers the origins and 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.

This course also provides a global view of the biomedical industry and the Safe Medical Devices Act. Quality assurance and quality control integration into research and development are also covered, including the role of quality in GMP, GCP, GLP and GDP.

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.
*Note that BQS 621 may be taken in place of this course.
Prerequisite: BQS 601

BQS 730. Introduction to Good Manufacturing, Laboratory and Clinical Practices (3 units)
Review of good manufacturing practices and good clinical practices from a quality control and quality assurance perspective.
Prerequisite: BQS 601

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

BQS 621. Quality Audits – Internal, Vendors, and Contract Services (3 Units)
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.
*Note that BQS 603 may be taken in place of this course.
Prerequisite: BQS 601