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Medical Device Regulatory Affairs: CE (Canada) and FDA
Expert has 25 years' experience in FDA, TGA, CE, and Health Canada product approvals for medical devices and combination devices. He has experience writing CER, CE applications, FDA applications, TGA and Health Canada applications. He has performed PMS, PMCF, recall,…
Quality Assurance, Regulatory Affairs, and New Product Development Consultant
BS Engineering, 30+ years in senior technical/management positions in Quality Assurance, Regulatory Affairs, and New Product Development space. Expert in medical device, in-vitro diagnostic, and pharmaceutical products and processes. Core competencies in Design Control, Risk Management, Validation and Verification, and…
Capillary Gas Chromatography, Petro-Chemistry and Miniaturisation, Method Development
Expert has been active in the field of chemical, instrumental analysis, especially (capillary) gas chromatography for more than 35 years. His work has covered almost all aspects, both analytical as well as instrumental, from environmental control (water and air analysis)…
Petroleum Processing Chemistry and Oil Products Compositional Chemistry
Expert was the lead process chemist supporting Acid Gas Amine Treating units in Shell US and Canadian Refineries and for Shell Canada Gas Plants. Expert also provided technical support Canadian Gas plants operating Shell licienced Amine systems (SCOTT and Sulfinol-D…
Lubricating Oil, Formulations of Aerosol Lubes and Lube Oil Chemical Additives. Re-refining UEO.
This expert has around 32 years of proven knowledge and expertise in lube oil and chemical additive component formulations and production, formulation of aerosols lubes, brake fluids, synthetic engine oils and various industrial, refrigerating, and transformer oils. Also in production…
Pharmaceutical Development
Expert has over 28 years experience as a pharmaceutical executive managing various aspects of drug product development, including outsourced pharmaceutical manufacturing and broad aspects of the CDMO industry. Previously, Expert was the President of Pharmaceutical Development Services and the Chief…
Product Design and Development; Plastic Part Design and Molding; Expert Witness, Patents
Expert has managed engineering and design consulting businesses since 1976. He has served clients in fields ranging from aerospace to sanitary services to medical monitoring and instrumentation. He has utilized his extensive experience in engineering, product development, manufacturing and aesthetics…
Automation, Special Purpose Machines for Assembly & Component Manufacturing, Leak Testing, Airflow
Expert has hands on experience of design, manufacturing, and production of automobile products. This also includes PFMEA, TGW,TGR, Process bench marking, Poka Yoke, Flexible manufacturing, SMED techniques..etc. Process design and development also part of automation. He has wide knowledge and…
DSP, Microcontrollers, Algorithms Design, Implementation and Optimization, Hardware Rampup and Debug
Freelancer Software Engineer with over 15 Years experience in DSP (TI - ALL), Microcontrollers (MSP430, PIC, ST ARM), BSP, Software Optimizations and Hardware Debug. Experience in wide verity of coding environments (MICROSOFT, TI, IAR…) for Embedded Systems. Experience in Algorithms…
cGMP Coatings, Pharmaceutical, Dietary Supplements, Adhesives, Die Cutting, Security Holograms, Printing, Operations Lean Management Metrics and Strategy, and Materials
Expert has worked in custom manufacturing – polymerization, mixing, coating and converting of cGMP adhesive and laminates - as a process engineering manager. In this role he lead operations and engineering on the corporate Business Strategy Team (BST) asserting direction…