CASSS CMC 09Dec14 Stephan Krause

The Analytical Method Transfer Process SK-Sep 2013

Risk-based Analytical Method Validation and Maintenance Strategies SK-Sep13

Bioprocess Summit - 03Aug15 - final SK27Jul15

CASSS CMC Strategy Forum Slides for 27Jan14 - SK21Jan14

The late-stage analytical method lifecycle - Risk-based validation and extension strategies (CDER 25June12) SK-May2012

Analytical Control Strategy for Biologics SK17Jan13

CPV Acceptance Criteria and Conditions SK09Aug16

AMV final 20Jun17

CPV Slides SK11Aug16 - Part 1 only

FDA (invited) Presentation - Specifications and Analytical Method Lifecycle for Accelerated Biologics - FDA Headquarters 28Sep15