Irvin Kluth is currently the Director and Lead Faculty for National University’s Biomedical Clinical, Quality and Regulatory Programs. He has been an active Adjunct Professor at Cal State University San Marcos (CSUSM), San Diego State University (SDSU), University of California at San Diego (UCSD), and the University of Phoenix (UOP) since 1997. In these capacities, he has supported the biomedical industry in the education and training of their future leaders in biomedical quality, regulations, and technology, with curriculum development, implementation, and student research. Prior to joining National University, he served as the Assistant Director and Adjunct Professor at SDSU in the graduate Biomedical Master of Science degree Quality Systems (BQS) and Regulatory Affairs (RA) 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 beginning his career 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, and the Millipore Corporation, he has held increasing levels of responsibility helping bring new biotechnology, device and drug products to market as well as ensuring their compliance, efficacy, safety, purity, quality, training, and adoption of quality systems for biomedical companies.
Mr. Kluth is a member of the American Society for Quality (ASQ), Regulatory Affairs Professionals (RAPs), and the Society for Quality Assurance (SQA). He presently is an active faculty member and sits on the Capstone/Thesis Committees.