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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 – Plan

    A comprehensive guide to planning an inspection readiness project for GCP compliance. This module covers the essential tasks and project management techniques involved in the Plan phase, helping teams prepare for regulatory inspections. Topics include creating an Inspection Project Plan, understanding inspector questioning, and the importance of debrief sessions.

    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
    Grade: Premium Performance

    SKU: CIR-1102-SPL01-EN Categories: , Tag:

    Description

    Learning Objectives:

    • Recall the key points from the first phase of an Inspection Readiness Project Plan — ‘Initiate’.
    • Describe the key tasks involved in the Plan phase of an Inspection Readiness Project.
    • Specify the key elements of a correctly structured Inspection Readiness Project Plan.
    • Describe each of the different question types that an inspector could ask during an inspection.
    • Explain why it is advisable to conduct a debrief session at the end of each inspection day.
    • Apply project management principles and techniques to the Plan phase of inspection readiness.

    Learner Benefits:

    • Master Techniques for Handling Inspector Questions: Become familiar with various question types inspectors may use and build confidence in answering effectively during the inspection process.
    • Develop Critical Project Management Skills: Gain insights into key project management tasks such as preparing, executing, and monitoring deliverables to maintain adherence to timelines and project goals.
    • Gain Confidence in Inspection Situations: Understanding different question types and how to respond will boost confidence in inspection situations.
    • Enhance Team Preparedness and Collaboration: Learn the value of daily debriefs and effective team coordination, ensuring everyone is aligned and well-prepared for each stage of the inspection.
    • Apply Knowledge to Real-World Scenarios: Benefit from practical applications of project management principles through scenario-based exercises, facilitating transfer of these skills to actual inspection readiness tasks.
    Module Features:

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

    Keywords

    • GCP Inspection Readiness
    • Inspection Preparation
    • Inspection Questions
    • Inspection Project Plan
    • Debrief Sessions
    • Project Management
    • Regulatory Compliance
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