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Laboratory Management; Quality Assurance/Control
Expert has demonstrated expertise with the design, development, and start-up of laboratory facilities. These facilities have been used for analytical testing, physical characterization, environmental sample conditioning, and drug stability testing. He has specified and implemented purified water systems, sample conditioning…
Software Quality & Life Cycle, ISO 9000 Standards, Software Regulatory Issues, etc.
Ms. D. Expert has extensive expertise with the maintenance, re-engineering, and reuse of computer software. She has maintained large telecommunications systems and established processes that resulted in effective provision of service to company engineers. She was the Chair of a…
Software Process Standards
Expert is considered an expert on the standards required to write software for the Web. He recently co-authored the book: A Guide to Standards and Specifications for Designing Web Software. He has published three books on software engineering standards and…
JIT Manufacturing, ISO 9000
Expert (pronounced Lub-ben) teaches ISO 9000 certification classes independently and through the University of California at Berkeley and Pacific Bell. His classes range from an introduction to ISO 9000 documentation and program development to surviving an ISO audit. He managed…
Chemistry and Instrumentation, Materials Science, ISO 9001, Regulatory Compliance, Asbestos
Expert has 23 years experience in laboratory management. He was a laboratory/chemistry assessor for two years at the New York Power Authority and a Senior Staff Chemist for Con Edison's Central Laboratory for 21 years. He is a laboratory auditor…
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…
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…
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…