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    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.

      Duration: 30 Mins

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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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