Topic 1. Challenges and Considerations for Implementation of ICH ...

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Output Example 2- Using QRM to Support Lifecycle Management of PP � Not all parameters are created equal � Recognizes a continuum of risk � Hard to define a critical process parameter � Helps put into perspective what is critical vs non-critical it is based on risk and clearly articulated � Management of risk can change over the lifecycle of product � How do we best report the change in risk due to new knowledge during lifecycle?
� Not discussed Output Example 3
Page 1 and 2: Topic 1. Challenges and Considerati
Page 3 and 4: Current Status Q11 � Step 1 EWG C
Page 6 and 7: Wrap Up CMC Focus Group Meeting May
Page 8 and 9: Breakout Session Overview Example 2
Page 10 and 11: Breakout Session Overview Example 4
Page 12 and 13: Q11 Output General Comments � Reg
Page 16 and 17: Output Example 4-Starting Materials

Topic 1. Challenges and Considerations for Implementation of ICH ...

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