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An acknowledged expert in computer system validation and compliance.
An extensive experience in the industry; a helpful hand also for system suppliers and those who have to comply with national and international regulatory rules.
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From automation to validation in the nineties >>> and now from validation to automation in the twenties 
The experience in various fields such as mechanics, electronics, petrochemistry, energy, pharmaceuticals comes from having worked in Engineering Companies, production Companies, plant maintenance, service Companies in Italy and abroad.
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From automation to validation
The experience in various fields such as mechanics, electronics, petrochemistry, energy, pharmaceuticals comes from having worked in Engineering Companies, production Companies, plant maintenance, service Companies in Italy and abroad.
Such experience deals with all aspects of - but not limited to - computer system validation from project management to execution of validation activities, on site as well as c/o the suppliers, including the studies required to comply with the predicate rules.
Such experiences are detailed in the curriculum vitae that includes also:
- cooperation with national and international associations, e.g. the award acknowledged by ISPE;
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- the steps to and results from professional qualification/ cooperation with associations, conferences chaired and seminars and training courses delivered, patent obtained, articles authored, including issues on GAMP (Good Automated Manufacturing Practice - Guide for Validation of Automated Systems).
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From validation to automation
From pharma positive experiences benefits to new application fields:
- At the end of a pharma project conducted jointly in accordance with the GAMP guideline to comply with regulatory rules, the IT professional became responsible of IT applications in an innovative and fast growing non-pharma Company. She therefore had the idea of applying an equivalent approach to manage and verify the outsourcer activities. Main purpose was to make use of the constructive aspects of the guidelines, regardless to the regulatory requirements, maximizing the use and practice of the methodology proposed by the IT supplier
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- Technical and procedural controls were implemented so that different developers could maintain homogeneous approach in the use of the declared methodology, avoiding rigorous restrictions but also undefined deviations; Documents produced accordingly evidenced that the results obtained from the configuration and testing activities could clearly be referred to the originating requirements
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Consulting services
The esperience as principal validation consultant covers all aspects of - but not limited to - system validation.
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Consulting services
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The extensive experience as validation and automation consultant, covers all aspects of automation and computer system compliance and validation. These include project management, validation planning, supplier auditing, risk assessment (including 21 CFR Part 11 assessment), system specification and testing (including protocol issue, execution and summary), SOP definition/revision, and all the related activities.
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This means the whole life cycle of the system, for most system types, including manufacturing equipment, process control, supervisory, environmental monitoring, Document Management, Laboratory Systems, Information Systems (in co-operation with IT specialists, when required).
Such experiences are detailed in the curriculum vitae.
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Training services
Training courses cover a choice of validation aspects usually in - but not limited to - the pharmaceutical area, where the applicable rules are mandatory.
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Training services
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Training courses cover a choice of validation aspects usually in the pharmaceutical area, where the applicable rules are mandatory. Recent conferences, e.g. those held during the Bias/BiMan 2004 (exibition web site - editor web site), are confirming that other areas may be - and are - applying the concepts, principles, rules and guidelines.
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Training on the job is an efficient way to take advantage of consultancy and assistance in order to have trained personnel, as individual or task force.
Training course contents are defined to acquire general information as well as detailed subjects and/or personalisation on specific requirements.
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Such experiences are detailed in the curriculum vitae.
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