BQS 603 Replaces BQS 621 as Required Course for BQS Degree Program

BQS 603 has replaced BQS 621 as a required course for the BQS degree program. Called "Foundational Quality Systems", BQS 603 is one of the two introductory courses in the Biomedical Quality Systems (BQS) program, the other one being BQS 601. Students will identify, define, describe and study the eight major global Foundational Quality Systems (FQS) on which other BQS are based, as listed below:

• Management Responsibility
• Equipment and Facility Controls
• Design and Development Controls
• Material Controls
• Change Controls
• Production and Process Control
• Data, Documents and Information Control
• CAPA

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. Additionally, students will study the impact of these FQS on worldwide directives, regulations and standards for biomedical products and the resulting relationship and impact on the other BQS. On a weekly basis, each of the eight FQS is explored from a global and macro perspective including the implementation strategy, and the function, role, and responsibility of the Quality Unit (QU) in ensuring FQS adoption and compliance. The course also covers the impact of these FQS on other functional operating units (FOU) of the organization. Furthermore, an emphasis is placed on the importance of the integration of FQS through all stages of the product lifecycle.

To encourage practical application, this course will make use of case study analysis requiring students to research legislation, statutes, and real-life biomedical company records involving the research and development and commercialization processes of the biomedical organization.

BQS 603 is also a required course for the Advanced Certificate in Biomedical Quality Systems.

This course will be taught be Mr. Irvin Kluth.

Irvin Kluth is an active Adjunct Professor at San Diego State University (SDSU) in the BQS program. Prior to joining SDSU, he served as a part-time instructor at the University of California, San Diego in the Executive Management and Extension Programs, and also for the University of Phoenix in their Bachelor and Master Degree Programs. Additionally, he is a Senior Executive Consultant for CHAR KLU Consultants. This consulting firm specializes in providing quality services to the Biomedical Industry such as auditing, CAPA, compliance, documentation, investigations, product review and release, and training.

Mr. Kluth has over 30 years experience in the biomedical industry starting with Baxter Laboratories in 1971 developing, scaling-up and manufacturing biological products. He was one of the earliest employees involved in the development, approval and launch of biotechnology products derived from monoclonal antibodies and large scale commercial columns. As an employee of large and small biomedical companies including BBraun, Dura and Elan Pharmaceuticals, he held increasing levels of responsibility, helping bring new products to market as well as ensuring compliance, efficacy, safety, purity, quality, training, and adoption of quality systems for Southern California biomedical companies. Mr. Kluth is a member of the American Society for Quality (ASQ) and the Society for Quality Assurance (SQA).