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Expert in Medical Device & Pharmaceutical Quality Systems; Regulatory. Affairs; Quality Fitness Reviews
Advised and trained Operations and QA employees in a large pharmaceutical plant on effective practices to investigate and document deviation events on the manufacturing floor and quality control laboratory. The aim of such investigations was to determine a root cause…
Expert in Medical Device Quality Assurance and Regulatory Compliance
Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…
Expert in Metallurgy, Welding Engineering, and Quality Assurance in the Pressure Vessel and Piping Industry
Expert has worked in the pressure vessel and piping industry, since 1975. He has worked as a metallurgist, welding engineer, QA manager, and consultant, Expert's experience includes the design, fabrication, and operation of various power and refinery plant components, including…
Expert in Air Pollution Monitoring, Project Design and Training, Pesticides Residue
Expert has experience in air pollution monitoring projects, project design and implementation, air quality monitoring stations, selection of continuous equipment and training, passive sampling of gases, landfill gases monitoring and testing, industrial emissions sampling and analysis, indoor pollution monitoring, medicinal…
Expert in Implementation and maintenance of Quality Management Systems, Pharmaceutical GMP for Excipients
Expert has applied his scientific background in various companies over the past 25 years. He has set up and managed spectrophotometric and electron microscopy laboratories - choosing and installing (including EDX and WDX analysers), undertaking research and developing a range…
Expert in Industrial Hygiene, Non-Friable Asbestos-Containing Materials, Formaldehyde, Silica, Indoor Air Quality, Mold, Accident Investigation, Auditing and Hazard Assessment
He has conducted numerous indoor air quality and environmental mold assessments for commercial and residential environments. Assessment includes monitoring for applicable indoor air consituents, developing corrective action plans, and verification of correction/efficacy. He also lead the indoor air quality committee…
Expert in Semiconductor Wafer and Packaging Materials, Process, Equipment & Quality
Semiconductor Manufacturing Processes and Control Electronic Assembly and packaging Project / Program Management Metallurgical Engineering & Materials Senior Western USA Consulting Manager for Digital Equipment Engineering and Manufacturing - likely 20+ major clients like Intel, Motorola, US Navy, Signetics, Medtronics,…
Expert in Total Quality, Supply Chain, Industrial Engineering, Lean Six Sigma, Baldrige, Project Management
Expert has taught Engineering Economics at Oregon State University. He has applied Engineering Economics to drive strategic decision-making in client companies, partnering with Stanford faculty to apply economic analysis in the design of Supply Chain networks in Pharmaceutical and Electronics…
Expert in Mold, Industrial Hygiene, Indoor Air Quality, Toxins, Environmental Microbiology, Formaldehyde
Expert has worked for over 30 years in studying the effects of contaminated air in a wide variety of work, office and residential environments. He has performed field studies and reviewed cases in hundreds of lawsuits involving exposure to heavy…
Expert in Chemical Analysis and Quality Assurance
She has expertise on Varian instruments ICP-AES; ICP-OES; AAS; GC-MS; NMR; Pelkin elmer ICP-OES; FT-IR; Schimatdzu HPLC; Elementar CHNSO; LC-MS; JEOL EPR; Bruker NMR operation and interpretation of results of various metal containing complexes and compounds of organic nature such…