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Explosives Instrument Detection, Trace Explosives Chemical Analysis, Optical Spectroscopy, Polymers
Expert has spent over 15 years working in the field of analytical chemistry of various labile organic compounds and macromolecules. He worked on the quantitative and qualitative analysis of highly involatile species that required special sample preparation and processing. These…
Management and Technology for Aluminum, Magnesium, Chemicals and Environmental
Directed the evaluation and selection of technology recommended for aluminum smelter expansions and new green site facilities. Directed equipment and technology retrofit in an operating plant to increase metal production by 10%. Directed the replacement of an existing plant-wide process…
Biotechnological Pharmaceutical Chemical Process Development Design Engineering
Expert has applied his extensive background in chemical engineering in various areas including pharmaceutical process and product development; developing new products for pharmaceutical and consumer industries; process, equipment, and analytical method validation in biotechnology areas; and designing and improving various…
Aseptic Process Design, Airflow Visualization, HACCP, PAI Preparation, Cleaning Validation
Expert has performed validation of aseptic processes including technologies such as blow-fill-seal, high-speed automated liquid and powder filling lines, lyophilization, barrier and isolation technology, and bulk pharmaceutical and biological processes. Expert has developed an airflow visualization procedure to assist the…
Environmental Chemistry: Analytical, Fate and Transport, Statistics, Validation, Data Management
Fundamental to almost every decision made in the environmental sciences are chemical analytical data describing the nature and extent of contamination or monitoring and environmental process or condition. It is rare, however, to find individuals who understand chemical analytical data…
Veterinary Drugs, Veterinary Pharmaceuticals, Animal Drugs, Animal Pharmaceuticals
Expert retired in 1992 from the FDA after a 29-year career. He spent his career in the FDA as a field laboratory analytical Chemist, a scientific coordinator in the management of Quality Assurance programs for field scientists, a program analyst,…
Biomaterials and Product Development R&D for Orthopedic, Cardiovascular, and Other Implants
Expert has helped assemble, and been lead author on 510(k) and IDE applications to the FDA. This has often included telephone conversations, and occasionally personal visits, with the FDA to discuss unique aspects of the devices and/or materials in the…
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…
Pharmaceutical Development & Validation
Expert has over 20 years of broad-based experience with pharmaceutical product development. His work in this area has ranged from early phase 1 drug characterization to phase 4 market product launch and validation. He has significant experience in bringing products…
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…