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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…
RFID, Operations Management, R&D Strategy, Project Management, Supply Chain & Logistics
Expert R. Expert was a pioneer in the "surface mount revolution" where he developed packaging, interconnect, process, and design technologies to enable high volume, small footprint manufacturing of two-way radios, cellphones, and pagers. He has led green field factory development…
Strategic Planning, Marketing, Sales, and Business Development
Expert has a proven track record in leading technology companies as president and in C-level executive positions. He holds an MBA and is certified by the Small Business Administration. His experience includes raising private financing, negotiating and setting up strategic…
Lean Manufacturing, Constraint Analysis/Resolution, New Product Planning, Manufacturing Engineering
Expert Kopstein (formerly Even) works with management and plant teams in the evaluation and implementation of advanced technology integration, efficiency improvement, waste reduction and productivity. Compliance and implementation of quality systems including aspects of ISO 9000, strategic planning, cost containment,…
Controlled Release, Microencapsulation, Drug delivery, Taste Masking, Bioavailability Enhancement
Expert has almost twenty years of experience in the formulation of pharmaceuticals for controlled release delivery. This work includes drug bioavailability enhancement, tastemasking, enteric protection, tableting, colonic delivery, prevention of ingredient interaction, nasal delivery, and buccal delivery. He has employed…
Knowledge Management
Expert is an internationally recognized authority on knowledge-management theory and practice. A pioneer in the knowledge-management field, he began designing and guiding the implementation of knowledge-management solutions for Fortune 500 companies in the late 80's, well before such terms as…
Sterilization; Food & Drug Product, Packaging & Process Development; HACCP & Validation
Expert is a nationally recognized expert in aseptic, retort and autoclave, thermal processing and associated packaging of foods and drugs. He is well networked with the FDA food regulatory agency technical staff, academia, other process authorities, and research consortia. He…
Web Coating Technology
Expert has spent over 28 years in the web coating industry. He has experience in wax coating, hot melt, solvent coating, solventless coating, and emulsion coating on a wide variety of webs, from light weight films and foils to SBS…
Fires, Explosions, Hazardous Chemicals, Chemical Burns and Toxic Exposure; Consumer and Industrial Products and Processes
CFEI, CPC, CChE, FAIC, FRSC, DABFET; Forensic Litigation Expert; Products Liability; Personal Injury Experienced, forensic expert witness for plaintiff or defense; both Federal and State. Accepting cases including, but not limited to: fires and explosions, hazardous chemicals, chemical burns and…