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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

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    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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