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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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    Out of Specification and Atypical Results

    This Module is aimed at personnel who require an overview of ‘Out Of Specification’ (OOS) and Atypical Results in the analytical laboratory, including how they are investigated, and how they can be prevented.

      Duration: 30 Mins

    SKU: PGL-1200-SPL04-EN Categories: , Tag:

    Description

    Learning Objectives:

    • Define the terms ‘Out Of Specification’ (OOS) and ‘Atypical Results’
    • Explain why OOS and Atypical Results are important
    • Describe how these results can occur
    • Describe ways in which OOS and Atypical Results can be prevented
    • Describe the sequence of steps taken to investigate OOS and Atypical Results
    Module Features:

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

    Keywords

    Assignable Cause
    Atypical Result
    Barr Decision
    EMA
    FDA
    Laboratory Error
    Non-Assignable Cause
    OOS Investigation
    Out of Specification (OOS) Result
    Resampling
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