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The top documents of stephan-o-krause-phd

CASSS CMC 09Dec14 Stephan Krause
CASSS CMC 09Dec14 Stephan Krause
63 views
The Analytical Method Transfer Process SK-Sep 2013
The Analytical Method Transfer Process SK-Sep 2013
225 views
Risk-based Analytical Method Validation and Maintenance Strategies SK-Sep13
Risk-based Analytical Method Validation and Maintenance Strategies SK-Sep13
71 views
The late-stage analytical method lifecycle - Risk-based validation and extension strategies (CDER 25June12) SK-May2012
The late-stage analytical method lifecycle - Risk-based validation and extension strategies (CDER 25June12) SK-May2012
47 views
Analytical Control Strategy for Biologics SK17Jan13
Analytical Control Strategy for Biologics SK17Jan13
51 views
Bioprocess Summit - 03Aug15 - final SK27Jul15
Bioprocess Summit - 03Aug15 - final SK27Jul15
87 views
CASSS CMC Strategy Forum Slides for 27Jan14 - SK21Jan14
CASSS CMC Strategy Forum Slides for 27Jan14 - SK21Jan14
41 views
CPV Slides SK11Aug16 - Part 1 only
CPV Slides SK11Aug16 - Part 1 only
91 views
CPV Acceptance Criteria and Conditions SK09Aug16
CPV Acceptance Criteria and Conditions SK09Aug16
85 views
AMV final 20Jun17
AMV final 20Jun17
179 views
FDA (invited) Presentation - Specifications and Analytical Method Lifecycle for Accelerated Biologics - FDA Headquarters 28Sep15
FDA (invited) Presentation - Specifications and Analytical Method Lifecycle for Accelerated Biologics - FDA Headquarters 28Sep15
953 views