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Medical Device Total Quality
FDA REGULATION. A significant portion of Expert's career has been devoted to FDA approval and regulation of medical devices, particularily those with significant risk. He is the President of a consulting company specializing in process validation, FDA/regulatory consulting, and auditing.…
Information Management
Expert has had over 30 years of experience in the laboratory environment. Prior to starting his independent consulting practice in 1985, he was employed in industry. He has been actively engaged in the use of computers for the management of…
Institutional Technology, Information Technology Applications, Information Technology used in Europe
COMPUTER-ASSISTED TEACHING. As Dean of the College at Employer from 1978 through 1985, Expert supervised and guided a nationally significant effort to incorporate computers and networking technology into educational programs of engineers and scientists. Since 1988, he has directed a…
Uses of Polymers, plastics, silver and other metals. EPA regulatory processes
For the past 25 years, expert has been actively involved in all phases of medical plastics synthesis, processing, and use. His experience includes custom formulation of polymers, analysis of medical markets, and selection of materials that will withstand the various…
X-Ray Imaging
Expert is the inventor, designer, and project scientist/program manager of a number of different X-ray imaging systems, ranging from satellite-based X-ray telescopes to large systems for nondestructive imaging of 50 ton rocket motors and nuclear pressure vessels. Expert has both…
Food Quality Control & Development
FOOD PROCESSING; FOOD PROCESSING EQUIPMENT; FOOD PRODUCTS. Expert's career has involved a wide range of products, equipment, and plant scale-up. He is particularly skillful in translating benchwork to successful plant manufacturing. FOOD QUALITY ASSURANCE AND QUALITY CONTROL. Expert has been…
Advanced PC Systems Design
Expert has focused his research and practice for the last several years on the design and implementation of PC-based office productivity systems. He has placed special emphasis on user interface design, decision support systems, and executive information systems. Expert is…
Electron Microscope, Light Microscopy, EBEAM Lithography and Nanofabrication, Scanning Electron
Expert has extensive experience in designing, implementing, troubleshooting, and interpreting experiments involving novel applications in all fields of biological microscopy (TEM, SEM). He also has expertise in confocal, fluorescence, DIC (Nomarski-Polarized), and other light microscopy techniques. His current work centers…
Pharmaceutical Technology, Manufacturing, Quality Systems and Regulations; GMPs and GLPs
Expert specializes in the field of pharmaceutical technology with particular emphasis on the development, manufacture, quality control and quality assurance of pharmaceuticals and medical devices. As a professional consultant to the healthcare manufacturing industries, he works with about 30 worldwide…
Quality Assurance Systems and Training
Ms. Expert has worked with numerous large and small organizations to establish and implement TQM processes. This process starts with an internal evaluation, then continues with policy and mission statements and the establishment of a steering committee to draw up…