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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…
Petroleum Refining Evaluation
Expert's company was founded as a consulting group of Registered Professional Engineers. As such, they serve clients worldwide in the energy industries, i.e. petroleum refining, natural gas processing, petrochemicals, chemicals, oil, and gas. Expert assists petroleum refining clients by applying…
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…
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…
R&D: Electrical, Mechanical, Plumbing, Energy, Computer room, HVAC, Ventilation, Clean Room, Design
Expert K. Expert is an expert in mechanical design. He and his associates provide a full range of mechanical design services, including mechanical system design, plumbing systems, energy compliance studies, and system field analysis for a wide variety of project…
Business Strategies
Strategic Planning; Project Planning; Performance Measurements; Balanced Scorecard: Expert has extensive experience in strategic planning, and C-level team facilitation. He has conducted strategic business planning for manufacturing, construction, publishing, distribution, and service industries. He has been involved with formulating mission…