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Orphan Drugs: FDA/EU/Canada; FDA Approval; Drug Development: CMC, QA, QC, Manufacturing
12 product approvals from FDA including 6 new chemical entities, a 510k device, and three major pharmaceutical efficacy indication supplemental approvals. All received 5-10 years of regulatory exclusivity (Hatch-Waxman, Orphan Drug). These products are generating over $100 million dollars in…
Engineering and Operations in Thick Films, Components and Fuel Cells
He has cost engineering experience in materials system and component development and manufacturing. As part of broader product development activities, only materials and processes which are consistent with cost targets are selected. Validating that cost targets are met are critical…
Efficient Utilization Steam, Steam Traps Selection, Steam Troubleshooting, Energy Conservation
Expert has over 25 years of experience as an energy conservation consultant in energy conservation and fuel saving 15% to 65% per month. He is a steam specialty consultant and undertakes pipeline & equipments' engineering drawings & selection/application. He also…
Supplier Quality & Development, Chemical Plant Operations
He is skilled in Problem Solving utilizing 5Why, 3Legged5Why, 5 Phase and 8D. He is also skilled in Layered Process Audits, Read Across/Look Across, 5S/Lean, Hidden Factories, Operator Support/Work Instructions, Planning & Prediction (PFMEA, Control Plan, Process Flow), Error Proofing,…
Wastewater Plant Design, Wastewater Plant Operation, Terrorism Prevention Engineering
He has over thirty years of experience as Environmental Manager, Engineer, Professor, Auditor, American Borate, Expert Witness, etc. Has ample expertise in the following: Civil and Environmental Engineering, Construction Inspection & Management, Business Development, Risk Assessment, Policy, Planning, Lobbying, Industrial…
Healthcare, Medical Device, Diagnostics, Pharmaceuticals coding, reimbursement
Expert, MD FACP AGAF FASGE FACG is a physician whose focus is strategy for coverage, reimbursement, quality improvement, bundled payments and accountable care. Executive clinician with over 30 years of experience providing strategic leadership and medical oversight to data-driven health…
Antitrust, Banking, Damages, Demography, Discrimination, Finance; IP Surveys, Statistics, Economics
Expert and his firm are responsible for all Quality Control on all litigation support activities for the Department of Justice. With an office of 15 professionals in the Washington DC metro area, they sample and evaluate the work of multiple…
Drilling and Completion Fluids, Chemicals, Processing and Drilling-Waste Management
CAREER PROFILE: - Expert has supervised the Drilling Fluids, Solids Control Equipment, Waste Generation & Waste Management in the international drilling sector since 1977. - As well as being a Drilling Fluids Specialist, he is very knowledgeable as regards drilling…
Nondestructive Testing including Radiography, Ultrasonic, Liquid Penetrant, Magnetic Particle
Expert is an ASNT (American Society for Nondestructive Testing) Level III certificate holder in UT (ultrasonic testing), RT (radiographic testing), MT (magnetic particle testing), and PT (liquid penetrant testing). He has held these certifications for 23 years and has recertified…
Industrial Hygiene and Safety, Infection Controls, Risk Assessment & Management, Investigation, etc.
He has worked in industry and as a consultant to industry performing injury and illness investigation and root cause analysis. Rate reduction requires an understanding of the contributing causes. As causes and key contributing factors were identified, physical conditions, programs,…