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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

    This module addresses both the ‘why’ and ‘how’ of Annex 1 CCS requirements, focusing on lyophilization to demonstrate application of Quality Risk Management principles in assessing and controlling contamination risks.

      Duration: 40 Mins

    SKU: CCS-1101-SPL01-EN Category: Tag:

    Description

    Learning Objectives:

    • Explain the purpose of the EU GMP Annex 1 guideline.
    • Outline the recommendations of Annex 1 relating to contamination control.
    • Define Quality Risk Management (QRM) and its purpose in pharmaceutical manufacturing.
    • Identify the key principles and steps involved in the QRM process.
    • Explain the role of QRM in developing a contamination control strategy.
    • Identify the key components of a comprehensive contamination control strategy.
    • Demonstrate how QRM principles can be applied to a lyophilization process to assess and mitigate contamination risks.
    Module Features:

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

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