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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 – Annex 1 and QRM

    The Annex 1 and QRM Module explains the ‘why’ behind Contamination Control Strategy (CCS) and Quality Risk Management (QRM) for all employees involved in sterile product manufacture. It provides a solid understanding of CCS and the holistic nature of contamination control, ultimately improving CCS design and implementation. The module is deployable on any LMS and can be branded and tailored to your company’s exact specifications.

    Interested in the ‘how’ of QRM and CCS? Please see our companion module Contamination Control Strategy – QRM in Practice!

    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: CCS-1101-SPL01-EN Categories: , Tag:

    Description

    Learning Objectives:

    • Explain the purpose of the EU GMP Annex 1 guideline.
    • Define Contamination Control Strategy (CCS) as per Annex 1.
    • Describe the potential consequences of contamination in sterile product manufacturing.
    • Explain the concept of Quality Risk Management (QRM) and its application to CCS development.
    • Describe the purpose of the four steps of the QRM process: risk assessment, risk control, risk communication, and risk review.
    • Explain the concept of Critical Control Points (CCPs) and their role in CCS implementation.
    • Discuss the importance of reviewing and updating the CCS to ensure continuous improvement in contamination control.
    		 Module Features:

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

    Keywords

    EU GMP Annex 1
    Contamination Control Strategy
    Critical Control Points
    Quality Risk Management
    Regulatory Compliance
    Risk Assessment    		 Risk Control
    Risk Communication
    Risk Management
    Risk Review
    Sterile Product Manufacturing

     

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