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Parasitology, Immunology, Microbiology, Bioterror Agents, Grant Writing, Med Writing, Expert Witness
Expert has extensive experience in the preparation and submission of 510(k) documents to the FDA for approval of Class II medical devices. His first work in 510(k) preparation and submission was in 1987 for acceptance of a rapid immunoassay for…
Machine Vision, Lasers, Laser-based Systems, Laser process, Light Processing, Optical Testing, Optics, Automation, Machine Design
Expert has developed automated inspection systems for various industries, that is, those systems needed for intermediate process control, as well as for final inspections. He is experienced with vision resolutions up to 4K by 4k with speeds up to 60…
Technical Commercial Development Support, Technology Transfer Food Non-Food Ingredients, Obesity
Expert K. Expert is the Principal of a consulting firm and has over 35 years experience in R & D., marketing, operations, process development and quality assurance. Expert engaged and managed a consulting business with network of experts that range…
Oil & Gas/LNG/Chemical Project Development & Management; Engineering & Construction
Expert F. Expert has applied professional chemical engineering knowledge, skills, and experience in evaluating, developing, and selecting alternative chemical process technologies, and has contributed to process improvements developed from existing technologies. Recent technical work involved devising an economical method to…
Drug Delivery Using MEMS, Ultrasound, Electroporation and Other Engineering Technologies
Expert has been the founder of two novel fields of transdermal drug delivery and has led a paradigm shift from chemical to physical methods to enhance skin permeability. He published the first paper establishing electroporation of skin. Using this approach,…
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…
Business Plans
Array Expert has developed and implemented chemical safety procedures for several clients, including a chemical recycling facility, and metal finishers using strong acid and alkaline chemistries, etchants, and electropolishing chemicals in their manufacturing and/or wastewater treatment processes. Activities include safety…
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…
Pharmaceutical Research and Product Development, Formulation and Analysis
Expert has spent nearly 25 years at Employer, teaching undergraduate and graduate courses in controlled drug delivery systems, pharmaceutical solutions, drug stability, drug diffusion and pharmaceutical rate processes. Before coming to USP, he was a teaching assistant at University of…