GCP Inspection Readiness – Close

Description

Learning Objectives:

• 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.

Learner Benefits:

• Gain Insight into Effective Inspection Closure: Learn how to successfully navigate the final steps of a GCP inspection readiness project, ensuring that all observations are addressed and that the inspection is closed out effectively.
• Enhance Response Strategies for Inspector Observations: Develop a solid understanding of how to handle and respond to observations in a close-out meeting, ensuring accurate and timely responses that align with regulatory expectations.
• Improve Documentation and Reporting Skills: Recognize the importance of preparing comprehensive internal reports, capturing critical insights, and implementing corrective actions to enhance future compliance efforts.
• Strengthen Team Collaboration and Debriefing Techniques: Appreciate the value of post-inspection debriefs, including how to conduct internal meetings that consolidate feedback and facilitate continuous improvement.
• Apply Project Management Principles to the Inspection Close Phase: Benefit from practical applications of project management techniques, empowering team members to carry out final tasks with accuracy and efficiency in a real-world GCP inspection context.