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6: Regulatory Responsibilities to Ensure Product Quality: Quality Systems, Quality by Design (QbD)

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Learning Objectives:
  • Quality by Design & Statistical Thinking
    • Quality Target Product Profile
    • Critical Quality Attributes
    • Risk Assessments
    • Experimental Designs
    • Practical vs. Statistical Significance
    • Visualization
  • Statistical Methods in Practice
    • Risk Assessment
    • Experimental Design
    • Visualization
  • Background and regulatory guidance on control strategy
  • Considerations for documentation of control strategy