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Increasing flexibility with control strategy | TechTalk
What is the optimal approach for change management in the control strategy evolution? ICH Q10 provides the basis for change management, while applying Q8 and Q9 principles provides opportunities to optimize the control strategy (Figure 4). Process parameters: Confirmation or optimization Confirmation of the design space(s), if used 4. In-process controls: Point of control Optimization of control methods Optimization and/or updating of models, ...
