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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 – Initiate

    An overview of a project management approach to preparation for a GCP regulatory inspection, with a focus on the key tasks, roles, and responsibilities of the Initiate phase. Explore how validation of inspection notifications, role assignment, and risk management are essential to a successful inspection outcome.

    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-1101-SPL01-EN Categories: , Tag:

    Description

    • Gain a Clear Understanding of Project Management Phases: Learn about the four key phases of an inspection readiness project and the importance of each, with an in-depth focus on the Initiate phase.
    • Perform Key Tasks in the Initiate Phase: Develop practical knowledge of essential tasks, such as confirming inspection notifications, identifying key personnel, and organizing the inspection project kick-off to ensure thorough preparation.
    • Improve Risk Management Awareness: Recognize common project management challenges and explore strategies to prevent potential pitfalls during the inspection readiness process.
    • Enhance Team Coordination and Role Definition: Learn to establish clear roles and responsibilities, ensuring each team member is prepared to meet inspector expectations and minimize inspection risks.
    • Apply Project Management Strategies to Real Scenarios: Engage in practical, scenario-based knowledge checks and exercises to strengthen your ability to apply key concepts effectively.

    Learning Objectives

    • Describe the key benefits of taking a project management approach to GCP inspection readiness.
    • Distinguish between the four project management phases of an inspection readiness project.
    • Define the roles and responsibilities of key team members in an inspection readiness project.
    • Describe the key tasks involved in the Initiate phase of an inspection readiness project.
    • Explain why an inspection notification must be validated.
    • Describe the common project management issues associated with the Initiate phase.
    • Explain how these issues can be avoided.
    • Apply project management principles and techniques to the Initiate phase of inspection readiness.

    Keywords

    • GCP Inspection Readiness
    • Project Management
    • Regulatory Compliance
    • Inspection Preparation
    • Risk Management
    • Team Roles and Responsibilities
    • Inspection Notification Validation

    Module Features

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

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