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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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    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!

    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-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

    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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