Process Validation: Process Design

• 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

Learner Benefits:

• Gain a thorough understanding of Process Design as part of Process Validation, focusing on building quality into biopharmaceutical manufacturing processes from the beginning.

• Learn about the three stages of Process Validation, emphasizing the importance of Process Design in ensuring products consistently meet quality specifications.

• Enhance your knowledge of essential quality management concepts, including Quality by Design (QbD), Quality Target Product Profile (QTPP), and Critical Quality Attributes (CQA).

• Learn how risk assessments are conducted to identify and control potential risks that may impact product quality.

• Explore risk assessment tools such as Failure Modes and Effects Analysis (FMEA) and Hazard Analysis and Critical Control Points (HACCP) to effectively manage and mitigate risks.

• Discover how a design space is established through Design of Experiments (DOE) to optimize process parameters and ensure consistent product quality.

• Understand the role of lifecycle management in continuously improving process capability and product quality.

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