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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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    Library

    Fundamentals of Process Validation

    Introduction to validation in regulated industries using case study of tablet manufacturing process. Includes validation masterplan, validation life cycle, specification, qualification and revalidation.

    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
    Grade: Core Library

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    SKU: PVF-1130-SPL02-EN Categories: , Tag:

    Description

    Learning Objectives:

    • Explain the term ‘validation’ and why it must be performed in regulated industries
    • List the five established validation categories
    • Explain the risk assessment approach to validation
    • Explain the purpose of a Validation Master Plan (VMP) and describe its contents
    • Explain the concept of the Validation Life Cycle
    • Describe the different stages of the Validation Life Cycle
    • Explain ‘traceability matrix’ and describe its use in validation
    • Explain the terms Design Specification (DS), Functional Specification (FS), and User Requirements Specification (URS)
    • Explain the purpose of process validation
    • Describe each of the four qualification stages: Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
    • Explain how the qualification stages relate to the equipment specifications
    • Explain the concepts of change control, revalidation and decommissioning
    		 Module Features:

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