James Bentson

Principal Consultant @ECI

Newport Beach, CA, US
MOBILE NUMBERS
+19•••••••86

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WORK HISTORY

Sep 2021 — Present

Principal Consultant @ECI

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Stevensville, MI, US

Enhanced Compliance Inc.(ECRx) works with medical device, pharmaceutical and biotech clients around the world. We provide a range of flexible and comprehensive services to ensure our clients meet FDA and global compliance regulation requirements, along with ensuring quality, efficacy and safety in bringing to market innovative life-changing – even life-saving – advancements in the life sciences field. Services include Non-Compliance (Consent Decree and Warning Letter) Remediation, Regulatory Compliance, Program Management, Manufacturing, Research & Development, Validation and Technical Services.

EDUCATION

1973 — 1978

Wayne State University

Bachelor of Engineering (B.Eng.), Industrial Engineering BSIE

1997 — 1997

UCLA Anderson School of Management

Ccertificate, Group Dynamics

SKILLS

Verification and Validation (V&V)Regulatory AffairsFacilities ManagementProduction ManagementIso StandardsManufacturingStart-UpsSoftware DocumentationQuality ManagementProcess OptimizationRoot Cause AnalysisQuality SystemQuality SystemsV&VProcess SimulationQuality EngineeringProcess ValidationU.s. Food and Drug Administration (Fda)Product DevelopmentValidationProduct LaunchR&DQuality ControlProcess MappingIso 13485Medical DevicesCapaDesign ControlCross-Functional Team LeadershipManufacturing EngineeringSopFdaProduct LaunchesEngineeringQuality AssuranceBusiness Process MappingChange ControlAuditingProcess Development

ABOUT JAMES BENTSON

Dedicated professional, experienced in: Research and Development, Manufacturing…

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