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Post Doctorate (Health Science – University of Southern California), Ph.D. (Biochemistry –American University)
M.S. (Biophysics-Michigan State University)

Kaiser Aziz completed a 29-year career with FDA where he was Director of Mechanics and Materials Science; Associate Director, Clinical Lab Devices; Chief, Clinical Chemistry, Hematology, and Pathology. He had a distinguished career as a clinical regulatory scientist and manager of device and drug evaluations, approvals, reengineering, standards, good manufacturing and quality system applications. He worked with individual and industry organizations in both design and total product life cycle (TPLC) approaches to pre-market applications for medical devices,pharmaceuticals and combination products. Prior to joining FDA, he developed and implemented quality assurance standard operating procedures and protocols for medical diagnostic systems in hospitals, physicians’ offices, and clinical reference laboratories.

During his tenure at FDA, he was an adjunct faculty in the Department of Medicine and Physiology, NIH Graduate School, where he developed and taught courses and workshops in Clinical Pharmacology, Therapeutic Drug Monitoring and Applied Laboratory Medicine. Currently, he is an adjunct faculty at the Center for Applied Health Sciences, Virginia Polytechnic Institute and State University, where he teaches medical device and pharmaceutical risk management courses and workshops. He has published numerous scientific and regulatory articles in professional and trade journals, and he has published several individual Text Book Chapters. He is a fellow of the National Academy of Clinical Biochemistry and Association of Clinical Scientists. He is certified as Clinical Laboratory Director by the American Board of Bioanalysis. He serves as a member of editorial advisory boards of professional journals. He was an invited guest editor on Nanotechnology and Clinical Trials in the Journal of Clinical Ligand Assay in 2006.

His expertise includes FDA’s quality system inspection techniques (QSIT), medical products risk management using hazard analysis and critical control points (HACCP), Nano-Biotechnology Device-Drug Clinical Trials Design and Management.

Kaiser Aziz , Ph.D., FACB, FACS

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