Building the House of Rapid Sterility - A Successful Platform Approach...

Presented by

Sophie Drinkwater at AstraZeneca and Jon Kallay, at Charles River Microbial Solutions

About this talk

Full Title: Building the House of Rapid Sterility - A Successful Platform Approach to introducing Rapid Methods This webinar will focus on the implementation of rapid sterility using a strategic platform approach to reduce the post-approval change burden, introduce the use of rapid methods earlier in the pipeline, and reduce validation time. It will also cover overcoming business challenges with alternative methods, perceptions of risk, regulatory challenges, and finance. It will discuss examples of these challenges regarding several products. This technology has been used both in development and commercial spaces, as these areas are very different and require different approaches to implementation. Although this presentation will focus on ATP bioluminescence, this approach may be used for all new alternative or rapid methods.
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