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Application of USP <665> Data to Support Qualification of Single-Use Systems

September 1 @ 10:00 am - 11:00 am EDT

This talk will focus on an overall application of USP <665> starting from risk assessment to qualification of disposable manufacturing systems based on USP<665> data set. All the key principles with examples where these principles need to be satisfied before one can apply the USP <665> data for disposable manufacturing system qualification will be discussed and illustrated. Lastly, different qualification approaches will also be presented to provide broader understanding.