Find an Expert
Lab Automation, LIMS, Validation & Data Analysis
Expert has developed validation plans and executed validation protocols on laboratory computer systems, laboratory information management systems, instruments and instrument data systems. He has consulted for several major pharmaceutical companies and teaches a course on chromatography data system validation at…
Process Control, Systems, and Optimization
Most recently Expert’s work has centered on pharmaceutical batch processes requiring Food and Drug Administration (FDA) software and hardware validation. Expert notes that generally, this requires a data model (both procedural and physical) following the guidelines of ANSI/ISA S88.00.02 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…
Biomedical Device Engineering
BIOMEDICAL PRODUCT DEVELOPMENT; MEDICAL DEVICE PRODUCT DEVELOPMENT; NEW PRODUCT DEVELOPMENT. Expert has dedicated his career to the research, design, development, engineering, and manufacturing of biomedical devices and instruments. Expert has directed medical device new product development projects and a product…
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…
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…