James Bentson
Principal Consultant at Eci
Based in Newport Beach, United States
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Seniority
Director
Department
General Business & Management
Location
Newport Beach
Industry
Business Consulting and Services
Company size
225
Contact information
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j•••••••@eci-rx.com
Phone
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Background
About James Bentson
Dedicated professional, experienced in: Research and Development, Manufacturing Engineering, Quality/ Regulatory and Operations Management, Auditing, Product & Process Development/ Optimization and creating GMP, ISO compliant quality systems. Specializing in Quality System Compliance, New Product submission/ launch, preparation for FDA ISO inspections and remediation of FDA sanctions such as 483 observations, warning letters and consent decree. Specialties: Set up of Start-up companies Facilities Design and Qualification Product & process development Establishing Quality & Mfg. Systems Regulatory submission FDA / ISO audit prep. Equipment Validation Risk Analysis FDA auditor/ reviewer Operations/ pilot line set-up SME :Design Control, Validation, Labeling, P & PC, Cal. & PM, CAPA, Complaints/ MDR, QA & QC Due diligence for acquisitions/ Venture Capital funding Establishment of sales and marketing programs
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