Risk Assessment Strategies in OSD Development and Manufacturing.
October 6th, 10am ET.
As clinical development progresses away from phase-appropriate formulations, the scale of drug substance and product increases to support automated manufacturing processes.
In this webinar, illustrative examples to mitigating scale up risks will be presented as well as:
- Performing risk assessments by stage
- Tools that can be used to de-risk during drug development
- What to look out for post phase 1
- Getting ready for process validation and registration
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