Module 3 - Strategic case studies in practice

Concluding Remarks  Systematic approach, begin with the end in mind  Identify CQAs based on patient's needs: safety and efficacy  Use science- and risk-based approach to identify material attributes and/or process parameters that may impact CQAs  Prioritize development studies and focus on the vital few potentially high risk material attributes and process parameters  Establish an appropriate control strategy  Consider discussing lifecycle management plans

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