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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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    GxP Good Documentation Practices – Principles

    Unlock the power of Good Documentation Practices (GDocP) in GxP-regulated industries to ensure regulatory compliance, product quality, and patient safety! Skillpad’s GDocP Module provides GxP employees with the ‘why’ of GDocP, crucial for establishing and reinforcing behaviors and practices that assure data integrity and compliance with ALCOA+ principles across both paper and electronic records.

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

    Description

    Learning Objectives:

    • Explain why Good Documentation Practices (GDocP) are essential in GxP-regulated industries.
    • Differentiate between directive documents and data collection documents.
    • Define data integrity in the context of GxP records.
    • Describe the relationship between ALCOA+ principles and the data integrity of GxP records.
    • Recognize the potential consequences of not adhering to Good Documentation Practices.
    • Explain the significance of signatures in GDocP for records.

    Learner Benefits:

    • Gain a comprehensive understanding of the critical importance of Good Documentation Practices (GDocP) in maintaining compliance with GxP regulations.
    • Recognize the significance of proper documentation to demonstrate product safety, quality, and regulatory compliance in GxP industries.
    • Learn the principles of data integrity and how to apply ALCOA+ principles to ensure accurate, reliable, and trustworthy records.
    • Develop a practical understanding of recordkeeping requirements, including the importance of signatures in creating accountability and preventing data manipulation.
    		 Module Features:

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

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