Creates value for customers with FDA and EU compliance, including remediation to resolve problems once and for all. Finds optimal solutions taking less time and resources because takes an analytical and intuitive approach that works! Clients appreciate my dedication, attention to detail to help figure out quickly what needs to be addressed, then doing it.Solves customer problems in design, manufacturing, quality, quality engineering and regulatory. FDA, notified bodies, remediation, compliance to cGMP & QSR, 21 CFR Part 4 (combination products), warning letter and injunction abatement etc. Prepared companies for inspection by notified bodies and FDA including compliance to regulations/standards and updating technical files.Cold chain process, supply chain specialist solving supplier issues. International experience includes India and Singapore.Applies practical and proven ideas to reduce business risks - loss of production, quality and market-share (reputation).Specialties: Remediation FDA and EUFDA complianceCAPARoot Cause AnalysisRisk Management ISO 14971Design ControlValidations - Test Method, design, process, package PackagingSterilization - EtO, Gamma, E-beamProduct developmentProcess improvementStatisticsQuality assurance and engineeringLean ManufacturingProject managementTechnology transfer