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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…
Adhesive Consulting, Formulating, & Research in Structural, PSA, Hot Melt, Epoxy, Urethane, & Wood
Expert D. Expert has done adhesive failure analysis projects in connection with establishing cause in litigation cases or in research and production problems. For example, a wood millwork manufacturer claimed an adhesive was faulty, resulting in customer loss and damages.…
Pharmaceutical Product Development, Drug & Medical Device Safety, Regulatory Affairs
Expert is active in U.K. General Practice with wide therapeutic area knowledge and practical patient prescribing. He has a good understanding of the U.K. health system, formulary adoption, N.I.C.E., and reimbursement. Expert has 15 years of experience in the design,…
Safety Management in Industry and Construction
At Abbott Laboratories (Ireland) Expert A. Expert served as the chief technical resource for the sterilization of medical devices by ionizing radiation (gamma) and ethylene oxide (EO). He was directly responsible for certification and validation of a number of gamma…
Fats and Oils: Chemistry, Health, and Nutrition
Since the early 1980s, Expert has been very active in the edible oils area. For eight years, he served as Chairman of the Biological Subcommittee of the Institute of Shortening and Edible Oils (ISEO), a trade association of refiners of…
Clinical Applications, Microbiology, Biotechnology, Diagnostics, Immunology, and Custom Speaking
Expert has been involved in the identification of biological molecules associated with disease and infection with bacterial and viral agents. By applying molecular techniques to vaccine and infection models, he has identified immunological (antigenic) markers of bacterial infections of human…
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,…
Health Conditions for International Trade in Fisheries Products, Food Safety, and EU Fisheries
Expert has worked in the Instituto Nacional de Pesca of Ecuador, developing industry codes of practice for processing and handling of farmed and wild-caught shrimp and shrimp products. Assisted with the design and implementation of export certification activities of $450…
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…
Management, New Product Development, and Plant Relocation and Startup
As part of top management's efforts to maximize revenue, growth and profitability, Expert has applied over 35 years of business, engineering and manufacturing expertise to provide cost effective solutions across a wide-range of industries. Expert maintains that it all starts…