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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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    Process Validation: Process Qualification and Control

    An overview of the qualification and continuing verification stages of process validation, intended to demonstrate that a biopharmaceutical process is capable of reproducible commercial manufacturing and to provide ongoing assurance that the process remains in a state of control.

      Duration: 30 Mins

    SKU: BPU-1112-SPL03-EN Category: Tag:


    Learning Objectives:

    • Explain the purpose of process qualification
    • State the pre-requisites that must be in place before process qualification can proceed
    • Summarize the activities that occur in process qualification
    • Explain the purpose of continued process verification
    • Describe some of the assessment tools used in continued process verification
    • Explain the role of change control in assessing changes to validated processes
    • Provide an example of where requalification would be necessary
    Module Features:

       Voice Over
        Knowledge Checks
       SCORM/AICC compatible
        Full Screen

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