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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…
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…
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…
Packaging Design, Development, and Testing
Expert's career in packaging has involved all aspects of design, development, and qualification testing of product and package systems. Protective packaging enables products to survive the normal transportation and distribution handling hazards of shock, vibration, compression, humidity, and temperature. He…
Fermentation, Product Recovery, Bioprocess Scale-Up, Bioinformatics, Former ISO 9000 Auditor
Expert (pronounced moy-man, ) is a former certified ISO 9000 auditor. Expert advises on productivity and quality assurance improvements, preparations for current Good Manufacturing Practices (cGMP) for FDA compliance. As an expert user of mainframes, minicomputers and microprocessors, he is…
Reliability, Maintainability
DERATING. Expert (pronounced gam-BALL-ee) is familiar with both government and industry derating guidelines pertaining to electrical and electronic parts. He has generated derating guidelines for engineers and given in-house training on their use. He has performed stress analysis on parts…