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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

    • Handle Inspector Questions Effectively: Become familiar with various question types inspectors may use and develop confidence in providing clear and accurate responses during inspections.
    • Perform Key Project Management Tasks: Learn how to prepare, execute, and monitor deliverables to ensure adherence to timelines and project goals.
    • Build Confidence in Inspection Situations: Understand different question types and response strategies to navigate inspection scenarios with assurance.
    • Strengthen Team Preparedness and Collaboration: Recognize the value of daily debriefs and effective team coordination to ensure alignment and readiness throughout the inspection process.
    • Apply Knowledge to Real-World Scenarios: Engage in scenario-based exercises to reinforce project management principles and support inspection readiness efforts.

    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.

    Keywords

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

    Module Features

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

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