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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 Design

    An overview of the process design stage of process validation, describing how a biopharmaceutical manufacturing process can be defined using a Quality by Design (QbD) approach that emphasizes accumulated scientific knowledge and quality risk management.

      Duration: 30 Mins

    SKU: BPU-1111-SPL07-EN Category: Tag:


    Learning Objectives:

    • Describe the rationale for having a structured approach to Process Design
    • Explain what is meant by ‘Quality by Design’
    • Explain the concept of a ‘Quality Target Product Profile’
    • Define Critical Quality Attribute (CQA) and provide some examples
    • Explain why risk assessment is done as part of process design
    • Explain the concept of manufacturing ‘design space’ with reference to Design of Experiments and Critical Process Parameters
    • Define Process Control Strategy and Operational Control Strategy
    • Define Master Production Record and explain its relationship to Process Design studies
    Module Features:

       Voice Over
        Knowledge Checks
       SCORM/AICC compatible
        Full Screen

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