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Immunoreagents, Clinical Reagents, Surfactant Science
Expert developed, created and adapted immunoassays for flagship auto analyzers. Using a variety of surfactants, he engineered reagents, controls and calibrators for immunoassays of thyroids (T3, FT3, T4 and FT4), reproductive hormones (FSH, LH, hCG and prolactin), anemia (B12 and…
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,…
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…
Registration of Drugs, Medical Devices, Cosmetics,Borderline Products; Reimbursement, expert witness
Expert has more than 30 years experience in the registration of ethical and OTC pharmaceuticals. He has worked with solid dosage forms, aerosols, sterile injectables, vaccines, topical products, and biotechnology products. He has registered new chemical entities, novel dosage forms,…
Mass Spectrometry, HPLC/MS, Ion Trap MS, LC/MS/MS in Environmental, Food, Proteomic, and Pharmaceutical Analysis
Expert has been hired by law firms as an expert witness in the area of analytical chemistry. He has worked with 15 law firms in his career, with some of the cases going over multiple years. This experience includes: •…
Physical Chemistry of Food & Drugs
FOOD CHEMISTRY; FOOD DRYING. Expert is a recognized authority in the physical chemistry of the stability of dry and semi-moist systems including foods, drugs, and biologies. His major research areas deal with the effect of temperature and are properties of…
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…
Materials Processing
SIZE REDUCTION OF SOLIDS; GRINDING (COMMINUTION). Expert (prefers "Expert") has spent a significant portion of his career in size reduction technology, chiefly involving himself with the identification, selection, and qualification of crushing, grinding, and milling processes. He has developed processes…
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…