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Machinery CE-Marking, Medical Device CE-Marking, CE-Marking with EU Authorized Representative Office
ISO 9000 IMPLEMENTATION; ISO 9000 AUDITING. Expert has expertise in implementing, documenting, and auditing procedures of medium to small companies that are pursuing ISO 9000 certification. Her organization provides training and consulting to implement ISO 9000, with emphasis on minimizing…
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…
Industrial Hygiene and Chemical Regulations, Asbestos
OCCUPATIONAL SAFETY AND HEALTH REGULATION; INDUSTRIAL HYGIENE. Ms. Expert' (Expert) career in occupational safety and industrial hygiene has always focused upon the understanding and implementation of OSHA regulations. While she has worked extensively in physical safety, her main emphasis has…
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…
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…
Educational Assessment and Curriculum Development for Early Childhood, Special Education Assessment
A significant portion of Expert's career in educational assessment has involved the research and development of assessment tools and procedures for young children and adolescents. She considers herself a problem solver who solves learning problems. She developed a screening test,…
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…
Compostable Packaging, Phase I ESA and Sustainability/Environmental Audits, Environmental Chemistry
Expert has extensive experience from his 45 years as a University Professor, Research Biochemist, CEO and Managing Partner. He was the CEO and technical director of an environmental testing laboratory. He is a Senior Scientist and managing partner in an…