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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.…
Molecular Biology, Molecular Pathology, Polymerase Chain Reaction Technology
Expert has expertise in the adaptation and development of molecular biological techniques to answer medical questions of human genetics, differential gene expression, diagnostics, epidemiology, and pathogenesis, particularly in regard to infectious agents and genetic diseases. The CGS is a multidisciplinary…
Laboratory Medicine, Pathology
Expert is experienced in the application of basic sciences to clinical and biomedical problems. Most recently, his interests have centered on infectious diseases, concentrating on pathogen-host interactions and biomaterials with special emphasis on biocompatibility. Expert's laboratory has recently elucidated the…
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…
Gastroenterology, Medical Use of Voice Recognition
A leading expert on the evaluation of medical lexicons, Expert is the American representative to the international group developing the minimal standard terminology to digestive endoscopy and has a major grant to test it in the U.S. The National Library…
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…