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Recorded Webinar
Biopharmaceutical Method Transfer – Using a Quality System Approach to Address FDA Method Transfer Concerns
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
This Webinar will discuss how non-compendial biopharmaceutical analytical method transfers can
leverage a risk-based approach to address Quality and Regulator concerns. Method transfers using a
statistical equivalence approach with tight criteria as frequently suggested by regulators makes it
difficult to transfer methods and can result in a high transfer failure rate. In this seminar we will introduce:
- Common regulatory expectations for method transfer
- Use of a risk-based strategy for method transfer
- Fitting method transfers into the larger Quality System
- Importance of method monitoring as part of the overall transfer strategy
- Introduction of the idea of an “Analytical Target Profile” to focus thoughts on method transfer.
At the end of the webinar attendees should have a better understanding of how to use a risk-based approach to method transfer that maximizes chances of successful transfers while minimizing Quality risks associated with a method transfer.
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