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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.…
Auditory Bioengineering, Sensory Aids, Hearing Loss, Passive & Active Protectors
Expert's main expertise lies in applying the combination of hearing science, audiology, and electrical engineering to the functional design of devices for the normal or impaired ear. This includes research on speech processing to improve understanding by the hearing impaired;…
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…
Engineering Materials
Expert has devoted most of his 35-year career to the application primarily of metals and other materials such as polymers, ceramics, composite materials, and electronic materials; he has also designed and manufactured machines and other structures. His expertise includes the…
Ceramics: Fabrication, Fracture, Powder Dispersion, Alumina, Nano-materials; Tapecasting, Creep, Sintering
Expert has been involved in ceramic processing since 1973. He served as a member of the research staff of the MIT Ceramic Processing Center. He has taught a graduate course at Rutgers University entitled "Colloid Chemistry of Slip Casting" since…
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…
New Drug Development and Approval
Expert has extensive experience in complying with requirements of that part of the Act pertaining to drugs as implemented by the regulations of the FDA The requirements affect the development of drugs from the initial stages of screening to final…
Workplace Safety, Product Safety, Mechanical Engineering, Workplace and Product Safety Surveys
Expert has expertise in product safety and liability reduction and specializes in electro-mechanical and mechanical systems. He has extensive experience in the areas of compressed gas systems, firearms, chainsaws, agricultural equipment, ladders, punch presses, power shears, power breaks, metal working…
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…
Enterprise Management Systems
Expert has spent a majority of his career involved in assisting companies select and implement systems to manage the process of manufacturing. His work has included almost every major software product for mainframe, mid-range, and minicomputers, as well as many…