QUALITY BY DESIGN (QbD)

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A hands-on two day workshop covering the key components of QbD concepts, implementation and product risk mitigation.

Key Learning Objectives:

• Understand Risk-Based GMP Compliance and FDA, ICH and ASTM Approaches
• Review Strategies for Defining Risk, Risk Factors and Risk Prioritization
• Understand the Basic Fundamentals and Approach of QbD
• Use QbD to Mitigate Product Risk in Engineering Drug Manufacturing Operations
• Understand the Connection Between QbD and Process Analytical Technology (PAT)
• Implement the Concept of Continuous Improvement

Including Multiple Interactive Exercises and Case Study Examples!