In this workshop we will be looking at the crucial elements and rule that will support sustainable inspections readiness. The 20/80 rules states that approximately 80% of effects in any given situation results from 20% of causes. We will be discussing how different operations and elements of clinical trials, inspections and audits could be impacted when applying this rule.

-        Explore the moral and ethical standards most commonly missed that can be identified through an effective audit

-        How data integrity differs in an internal to external context, and gauge what steps can be taken to ensure vendors deliver at a required standard

-        Realise how the validation process is crucial to audits by understanding what processes are under your responsibility, whether these standards match with your chosen vendors, all whilst in-keeping with required regulatory standards.

-        Look at processes on sites, documentation is there, information is included, document can be easily located

-        What can you do as a person or group to ensure the integrity of data. Learn how to manage these steps with a risk-based approach