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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.…
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…
Computer Simulation, Space Shuttle Logistics, and Database/Web Application Design Operations Analysis
LOGISTICS; OPERATIONS RESEARCH. Expert's Ph.D. is in Operations Research and he has taught graduate and undergraduate courses in the area. He has been intimately involved in Space Shuttle logistics since 1982. His primary interests include probabilistic systems analysis, logistics, queueing,…
X-Ray Imaging
Expert is the inventor, designer, and project scientist/program manager of a number of different X-ray imaging systems, ranging from satellite-based X-ray telescopes to large systems for nondestructive imaging of 50 ton rocket motors and nuclear pressure vessels. Expert has both…
Bar Coding, Automatic Identification, Printing, and Optics
Expert has spent many years designing and building bar code equipment and consulting on bar code technology. He has consulted on retail, shipping, medical, manufacturing, electronics, and other industrial and commercial bar coding applications. Over the last 15 years, Expert…
Space/Rocket Systems & Voice Mail
Expert E. Expert, Jr. has 23 years experience in the management of both projects and programs as well as research and development specialty engineering groups. He has a profound understanding of human nature and, as a result, the ability to…
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…
Enterprise Management Systems
Expert has spent a majority of his career involved in assisting companies select and implement systems to manage the process of manufacturing. His work has included almost every major software product for mainframe, mid-range, and minicomputers, as well as many…
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…