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Developmental and Reproductive Toxicology Study Design, Data Evaluation, and Report Review
Expert (prefers “Expert”) has acquired knowledge and expertise on birth defects in three ways: 1) teaching university courses on human embryology and on causes and manifestations of birth defects; 2) conducting lab animal research; and 3) extensive technical consulting and…
Practical Application of GLP, GCP, and cGMP to Pharmaceutical, Device, and Biotechnology Firms
As Vice President at a pharmaceutical company, Expert formulated eight pharmaceuticals for use in their patented buccal delivery platform technology. Five formulations were acceptable to FDA and were allowed to proceed into human clinical trials under IND controls. Four of…
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…
Facilitating Business Growth Through Commercialization of New Medical and Biotechnology Products
Expert has extensive experience supporting clients in pharmaceutical, medical and industrial markets. An electrical engineer by training, and the principal of his own consultancy for more than 12 years, he brings strong market, business development and technical skills to his…
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…
Basic and Applied R&D – Commercial and Government Projects in Physical Sciences and Engineering
Expert is an expert in all aspects of experimental research. He is proficient in conceptual design through R&D, prototyping, and testing. He is also proficient in many technology areas including digital and analog electronics, data acquisition; optics and electrooptics; mechanical…
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…
Bioprosthesis, Cardiac Valves, Biocompatible Materials, Cardiovascular Diseases, Biomedical Eng.
BIOMEDICAL ENGINEERING. Expert has expertise in biomedical engineering, particularly in the areas of prosthetics and implantable devices. HEART VALVE PROSTHESIS; CARDIAC VALVE. The bulk of Expert's research has been related to heart valve prosthesis. His work has focused on the…