Contenuti:
Nel corso della giornata verranno trattati i seguenti argomenti:
· ALCOA and data integrity: past and future
· Site Data Integrity Road Map: towards a goal
· Paper, paperless and hybrid systems
· Risk assessment approach to data integrity
· Inspections to API manufacturers on data integrity by Authorities
· Remediation Plan: risk mitigation
· Data integrity : policy, SOPs, check-lists
· Data Integrity in the supply chain
· Case histories
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