2nd GCP Inspection Readiness

Topics

• Current inspection risks to provide the building blocks for your GCP inspection readiness plan
• Quality culture as the heart of any successful inspection readiness plan
• The current regulatory environment and the impact on GCP inspections
• Mock inspections as a quality tool to focus risk mitigation efforts
• All stakeholders understand their role leading up to and during an inspection
• The power of the Trial Master File (TMF) to drive inspection readiness processes
• Sequence of events for managing an inspection to understand the different roles
• GCP audits to assess the inspection readiness of your clinical vendors and sites
• Training as a core component to an effective inspection readiness approach