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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…
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…
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…
Web Development, Database Driven Wrb Applications dDvelopment, Yahoo! Stores and Ecommerce Solutions
Expert has spent the past 20 years in engineering of surface mount technology (SMT) and hybrid microelectronics. He has concentrated on automated assembly and design for manufacturability. He founded AMTI (The Advanced Manufacturing Technology Institute) to provide a core group…
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…