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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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    Contamination Control Strategy – QRM in Practice

    This CCS-QRM in Practice Module unlocks the ‘how’ of using Quality Risk Management (QRM) to successfully devise, implement, and maintain your facility’s Contamination Control Strategy (CCS). Using the example of contamination control in a lyophilization process, the user explores and applies QRM steps, including risk analysis, risk control, and corrective action planning. Suitable for both new and existing facilities, the module is deployable on any LMS and can be branded and tailored to your company’s exact specifications.

    Interested in the ‘why’ of Annex 1 CCS requirements? Please see our companion module Contamination Control Strategy – Annex 1 and QRM!

      Duration: 30 Mins

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

    Description

    Learning Objectives:

    • Identify key Annex 1 requirements for contamination control in sterile product manufacturing.
    • Explain the application of Quality Risk Management (QRM) principles to devising, implementing, and maintaining a CCS for lyophilization.
    • Describe the tasks involved in applying HACCP to the Risk Assessment step of QRM.
    • Define Critical Control Point (CCP) and provide examples of CCPs for a lyophilization process.
    • Describe tasks for applying HACCP to the Risk Control step of QRM.
    • Recognize the importance of actively reviewing and updating a CCS as per Annex 1 requirements.
    		 Module Features:

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

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