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Founded in 1998 in Dublin, Ireland, Skillpad's team of industry-experienced Subject Matter Experts and Consultants believes Pharma, Biopharma, and Life Science Industry manufacturing companies can achieve production excellence with improved performance, productivity & compliance, as well as reduced losses & down-time, if they have KNOWLEDGE CONSISTENCY in all critical areas of manufacturing operations.

With 25 years in business, and offices in Europe, the USA and Canada, Skillpad has helped customers all over the world with Life Science Industry Knowledge challenges. We are fully dedicated to the idea that Knowledge Consistency is more achievable than ever using the latest technology and advanced knowledge transfer and management tools.


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    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

    SKU: CIR-1104-SPL01-EN Categories: , Tag:


    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.
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