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Biomedical Device Engineering
BIOMEDICAL PRODUCT DEVELOPMENT; MEDICAL DEVICE PRODUCT DEVELOPMENT; NEW PRODUCT DEVELOPMENT. Expert has dedicated his career to the research, design, development, engineering, and manufacturing of biomedical devices and instruments. Expert has directed medical device new product development projects and a product…
Physical Chemistry of Food & Drugs
FOOD CHEMISTRY; FOOD DRYING. Expert is a recognized authority in the physical chemistry of the stability of dry and semi-moist systems including foods, drugs, and biologies. His major research areas deal with the effect of temperature and are properties of…
Energy & Process Piping Design
PIPE; PIPELINE; CIVIL ENGINEERING. Expert has over 35 years of experience in mechanical and civil/structural engineering, principally in the design and analysis of industrial process and energy-related structures, equipment, piping, pipelines, and support. PIPING CODE; BOILER CODE. Expert is an…
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.…
Petroleum Refining Evaluation
Expert's company was founded as a consulting group of Registered Professional Engineers. As such, they serve clients worldwide in the energy industries, i.e. petroleum refining, natural gas processing, petrochemicals, chemicals, oil, and gas. Expert assists petroleum refining clients by applying…
Medical Technology
A significant portion of Expert's current activities include maintaining awareness and working knowledge of regulations that impact medical device manufacturers. She has specific experience with new medical device submissions, including combination products. Expert is proficient in total quality systems requirements…
Industrial Hygiene and Chemical Regulations, Asbestos
OCCUPATIONAL SAFETY AND HEALTH REGULATION; INDUSTRIAL HYGIENE. Ms. Expert' (Expert) career in occupational safety and industrial hygiene has always focused upon the understanding and implementation of OSHA regulations. While she has worked extensively in physical safety, her main emphasis has…
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…