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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.


Apply for this webinar

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