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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.

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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.

    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

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    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

    Learner Benefits:

    • Clear Understanding of OOS and Atypical Results: Gain a comprehensive understanding of OOS and Atypical results, their definitions, and why addressing these outcomes is crucial in pharmaceutical quality assurance.
    • Knowledge of Regulatory Requirements for Investigations: Learn about regulatory mandates such as the FDA’s Barr Decision, emphasizing the need for thorough documentation and scientifically sound investigations of OOS results.
    • Insight into Investigation Processes and Protocols: Acquire step-by-step knowledge of laboratory and production investigations, including initial assessments, identifying assignable causes, retesting protocols, and conditions for resampling.
    • Skill in Identifying and Mitigating Common Errors: Understand common sources of laboratory errors and process deviations, equipping you with best practices to prevent OOS occurrences, improve testing accuracy, and ensure quality control.

     

    		 Module Features:

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

    Keywords

    • Analytical Testing
    • Assignable Cause
    • Atypical Results
    • Barr Decision
    • Investigation Process
    • Laboratory Error
    • Out of Specification (OOS)
    • Process Error
    • Quality Control
    • Regulatory Compliance
    • Standard Operating Procedure (SOP)

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