Join Us | Oct 20 mindsON RBQM Episode 9
QTLs; Necessary but too complicated? As significant deviations to QTLs need to be reported in the Clinical Study Report, setting up QTLs can be challenging.
QTLs; Necessary but too complicated? As significant deviations to QTLs need to be reported in the Clinical Study Report, setting up QTLs can be challenging.
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ICH E.6 (R2) Scope of and need for Gap Analysis WEBINAR PROGRAM • ICH E.6 R2 History, Changes and Scope • Risk-based Quality Management • Quality Tolerance Limits • Risk-based Monitoring Plan • Examples • Gap Analysis • Electronic Media Validation • [...]