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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 – Execute and Monitor

    Practical strategies for executing and monitoring a GCP inspection readiness project. This module focuses on the critical third phase, covering activities such as managing inspector interactions, overseeing document preparation, and monitoring deliverables, with a goal of ensuring compliance and readiness during a GCP inspection.

    Whether for onboarding or annual refresher training, this Module is seamlessly deployable on any LMS and can be tailored to your company’s exact needs.

      Duration: 30 Mins

    SKU: CIR-1103-SPL01-EN Categories: , Tag:

    Description

    Learning Objectives:

    • Recall the key points from the second phase of a GCP Inspection Readiness Project Plan – ‘Plan’.
    • Describe the key tasks and activities of the Execute and Monitor phase of an inspection readiness project.
    • List typical issues or areas that are examined during a GCP Inspection.
    • Explain why specific Core team members are assigned responsibility over key documents for a GCP Inspection.
    • Explain the purpose of preparing an organizational chart for an inspector.
    • Describe the consequences that can result from failing to execute key tasks in the Execute and Monitor phase.
    • Apply project management techniques to the Execute and Monitor phase of inspection readiness.

    Learner Benefits:

    • Develop Essential Skills for GCP Inspection Readiness: Understand the critical tasks and responsibilities involved in the Execute and Monitor phase to effectively navigate an inspection and ensure compliance.
    • Master Techniques for Inspector Engagement: Learn best practices for interacting with inspectors, including preparing answers to potential questions and managing daily inspection debriefs.
    • Strengthen Team Coordination and Accountability: Gain insights into the importance of assigning document responsibilities to Core team members and using organizational charts for clear role delineation.
    • Enhance Risk Management and Problem-Solving Abilities: Discover how to identify and address potential issues proactively, ensuring all deliverables are executed correctly and on time.
    • Apply Knowledge Through Scenario-Based Learning: Experience practical, scenario-based training, enabling confident execution and monitoring of tasks in a real-world GCP inspection setting.
    Module Features:

        Animations
       Voice Over
        Knowledge Checks
        Assessments
       SCORM/AICC compatible
        Full Screen

    Keywords

    • GCP Inspection Readiness
    • Execute and Monitor Phase
    • Project Management
    • Regulatory Compliance
    • Project Team
    • Inspection Preparation
    • Risk Mitigation
    • Operational Efficiency
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