stephan-o-krause-phd documents

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