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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 Computerized Systems Validation

    Explains the fundamentals of computerized systems validation and the validation process as recommended in the GAMP® guideline. Also introduces the FDA’s 21 CFR Part 11 ruling on electronic records and signatures.

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

    Description

    Learning Objectives:

    • Define ‘computerized system’.
    • Explain the purpose of computerized system validation.
    • Explain the purpose of the 21 CFR Part 11 regulation.
    • Define ‘risk’ as it relates to computerized systems.
    • Describe how software in computerized systems is categorized.
    • Explain the purpose of incorporating CSV into the system life cycle approach.
    • Describe the activities involved in the project phase of CSV.
    • Explain why risk management must be done throughout the operating phase of a computerized system.
    		 Module Features:

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