Mike Denton

Mike Denton is a business owner, validation/test engineer and project manager in the world’s commercial services industry. He is an experienced subject matter expert with 11 years of focus in the development, edification and enforcement of GxP Computer System Validation and Quality by Design methodologies ensuring FDA-GMP/GLP/GDP/ISO/SOX conformity of Quality Systems in the Pharmaceutical, Nutraceutical, Biotechnology, and Medical Device segments. His IT validation and project management experience utilizing multiple SDLCs include SAP (ERP, Solution Manager, Tao), CRM (Siebel), HP Quality Center (QTP), ARIS, SAP, MES, EDMS, CAPA, lab equipment and many other high risk systems.

Specialties: User Requirements, System (Functional) Requirements, System Design Requirements, Installiation Qualitifcation, Operational Qualifcation, Performance Qualitifcation, ISO, FDA, SOX, Part 11, Risk Management, Testing, Process Development, Six Sigma, PMP, SAP Cutover, OPEX, Change Managment, Security, Communications