GCP Inspection Readiness – Close
Provides practical techniques and strategies for the Close phase of a Good Clinical Practice (GCP) Inspection using project management principles. This includes preparing for close out meeting, performing close out meeting with the inspector, responding to observations (483s), finalising the internal report and defining lessons learned.
Duration: 30 Mins
- Recall the key points from the third phase of an Inspection Readiness Project Plan – ‘Execute and Monitor’.
- List areas where observations are typically made in a GCP Inspection.
- Describe the purpose of holding a close out meeting with an inspector.
- Explain why an internal team meeting should be held before the close out meeting.
- List the key tasks involved in the Close phase of an inspection readiness project.
- Explain the importance of responding correctly to inspection observations.
- Describe the consequences that can result from not executing or failing to execute key tasks in the Close phase of an inspection.
- Explain the value of preparing an internal inspection report.
- Apply project management principles and techniques to the Close phase of an inspection readiness project.