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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.…
Metal Can Manufacturing and Filling Problems, Printing, Anilox Rolls, Inks & Coatings, etc.
Expert has over 20 years of experience in the metal container industry with specific emphasis in can manufacturing, R&D, interior and exterior can coatings, can evaluation, cost reduction analysis, chemical/ physical testing of can components and canned products, and can…
Microelectronics Processing and Contamination Control, Cleanrooms, Particulates, Ultra High Purity
Expert has twenty years of research experience in semiconductor technology in major industrial laboratories. This, combined with his expertise gained by fifteen years managing microelectronics laboratories where he performed semiconductor fabrication research at two major universities (Minnesota and Arizona), makes…
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…
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…
Dairy and Food Technology
DAIRY PRODUCTS. A major portion of Expert's formal education was devoted to dairy products manufacturing. He teaches courses at the University of Wisconsin on dairy product design and milk, butter, cultured products, and frozen dessert manufacturing. He also teaches short…
Offshore Sourcing (particularly in China) of OEM Parts, International Manufacturing, Vendors, & ECO
OFFSHORE (INTERNATIONAL) SOURCING OF OEM PARTS; FOREIGN SOURCING; ENGINEERING CHANGE ORDER (ECO). Expert and Expert's company specializes in the area of offshore sourcing of OEM components from China. He advises manufacturers of mechanical, electronic, and electro-mechanical products on drastic reductions…
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…
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…