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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…
Software Engineer, Testing, QA
COMPUTER SOFTWARE ENGINEERING; SOFTWARE DEVELOPMENT TOOL; SOFTWARE TESTING. Expert is Chairman and CEO of a software company. He is a leading figure in the software engineering community, specializing in advanced technology for software testing, software verification and validation, automated software…
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…
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…