David Bini Email & Phone Number

PMP certified since 2016.Project Manager and Executive Consultant, 10+ years of experience in Project Management and Computer System Validation, IT Assessment, IT Infrastructure Qualification, Risk Analysis and Assessment to ensure the compliance with requirements and regulations given by the US FDA, EU authorities, and other International and National Standards, as well as IT, QA, Clinical rules and guidelines. Validation team coordination in terms of software system user requirements and support for implementation, release, tuning and testing of GxP critical systems for pharmaceutical and medical devices industries in Italy and Europe. IT Infrastructure team coordination for the Qualification of IT Infrastructure.Wide experience in pharmaceutical processes (analysis and mapping for production, Clinical, warehousing, QA, distribution, plant maintenance and logistics) and the associated IT solutions.Software development Skills focused in the implementation of application supporting Medical Device, Pharmaceutical and Clinical Processes.Appointed as SW Vendors / System Integrator Auditor.

Listed skills include Validation, Computer System Validation, Gmp, Gxp, and 18 others.