IT Compliance Consultant & Computer Systems Validation Consultant.Qualification and Validation of ERP, EDMS, Data Center, IT Infrastructures, MES, Dispensing System, SAS, DCS, SCADA, PLC, Machinery, HVAC, LIMS, CDS, Laboratory instruments, Spreadsheets, Databases, Warehouses Management System, BarCode/Rfid System.Consulting and training for Computer System Validation, FDA 21 CFR part 11, Compliance to GxP regulations, Quality Management Systems.Auditing for supplier selection and qualification.Definition, preparation and review of IT Standard Operating Procedures.Compliance Assessments: Validation Master Plan, GxP Risk Analysis, Periodic Review, Remediation Plan.

GxP Consultant in GMP, GLP and GVP area - CSV (Computer System Validation) ConsultantAbiogen Pharma S.p.A. is an Italy based pharmaceutical company, with a great experience widespread in all the different areas of activity of the pharmaceutical sector, this thanks also to the strong interaction developed and existing among its Research, Manufacturing and Pharma sales areas. Abiogen provides high quality standards pharmaceutical development and manufacturing services, including process R&D, analytical method development, scale-up, validation and commercial scale production. Abiogen manufacturing capabilities cover many finished dosage forms, including solid, semi solid, liquid and aseptic filling formats. The experienced team of specialists guarantee customers with their production and development needs.

Galileo Research è un laboratorio accreditato in GLP (Buone Pratiche di Laboratorio) dal 1990Galileo Research : GLP (Good Laboratory Practices) accredited “Testing Facility”

Computer Validation (GCP, GLP, GMP) ManagerHead of the Centre at Temperature and Pressure Calibration Laboratory - CENTRO di TARATURA SIT n. 200 ( www.sit-italia.it ) :planning and implementation of a metrological laboratory for temperature and pressure measurement; implementation of Quality Manual and technical, quality and calibration procedures, to obtain the Center SIT (the Italian Service Calibration) accreditation of the lab. in compliance with ISO/IEC 17025 standard

Biomedical Laboratory BIMLab, University of Florence DSI departement (Dipartimento di Sistemi e Informatica) : planning and implementation of communication devices.