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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.…
Instrumentation: Project Management, Marketing, and Sales
Expert has spent 25 years in instrumentation, dealing with the end instruments listed next to this paragraph. He has designed, improved, and used all of these in all types of applications. He lays emphasis on reliable use, even under unique…
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…
Pesticide Toxicology, Pesticide Chemistry
Expert has conducted research in pesticide toxicology and chemistry, focused primarily on insecticides, including the chlorinated hydrocarbons (such as DDT, methoxychlor, dieldrin, and heptachlor), the pyrethroids (such as pyrethrum and many synthetic pyrethroids), organophosphates, carbamates, and natural products. His work…
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…
Cough Medicine, Smoke Effects on the Lungs, Vivo Assessment of Airway Clearance, etc.
Expert has expertise in mucus rheology, coughing and cough clearance. His research in mucology involves the study of airway surface fluid (ASF) and how it contributes to lung defense. ASF, the secretory product of the respiratory tract, is composed of…