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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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    Overview of GxP

    This Module is aimed at personnel who require an overview of the background, purpose, and implementation of GxP regulations (GLP, GCP, GMP) that aim to provide assurance of the safety, efficacy, and quality of pharmaceutical products. It also details the consequences of non-compliance with these regulations.

      Duration: 30 Mins

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    SKU: GXP-1200-SPL01-EN Categories: , , Tag:

    Description

    Learning Objectives:

    • List the three characteristics that all drug products must possess
    • Describe the drug development and approval process
    • Define GxP and why it is necessary
    • Explain GLP, GCP, and GMP in terms of their specific objectives
    • Describe the functions of regulatory agencies such as the FDA and EMA
    • Describe the consequences of non-compliance with GxPs
    		 Module Features:

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

    Keywords

    Clinical Trials
    Drug Products
    Efficacy
    Good Clinical Practices
    Good Laboratory
    Practices    		 Good Manufacturing
    Practices
    Nonclinical Studies
    Quality
    Regulatory Agencies
    Safety

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