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!