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PK/PD Modeling and Simulation; Nonclinical and Preclinical Statistics; Experimental Design
He managed group of 5 biostatisticians working on Phase I and PK/PD trials. His responsibilities included protocol design, statistical analysis plan writing, specification writing, and delivery of product to customers. He was responsible for meeting all timelines and budgets, assuring…
Engineering Management
Expert has been involved with the re-engineering of new product development processes, creation of total quality management programs, and organizational structure changes for process engineering and research and development functions for two major medical device manufacturers (i.e. Johnson & Johnson…
Near-Infrared Spectroscopy, Statistics, Chemometrics, and Software Development
Expert has expertise in the design and development of spectroscopic instrumentation, particularly in the near-infrared spectral region. He was on the design team for several of the instruments produced by a major manufacturer. He was the chief system troubleshooter, integrating…
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…
Satellite Telecommunications
President and CEO Ms. Expert and her staff at Employer offer an aggregate of over 200 years of experience in the satellite communications revolution. Employer's company headquarters are in Fairfax, VA with remote offices in Atlanta, New Orleans, Colorado Springs,…
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…
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.…
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…