Front Matter -- Introduction to Quality by Design (QbD) / Bruce Davis, Walkiria S Schlindwein -- Quality Risk Management (QRM) / Noel Baker -- Quality Systems and Knowledge Management / Siegfried Schmitt -- Quality by Design (QbD) and the Development and Manufacture of Drug Substance / Gerry Steele -- The Role of Excipients in Quality by Design (QbD) / Brian Carlin -- Development and Manufacture of Drug Product / Mark Gibson, Alan Carmody, Roger Weaver -- Design of Experiments / Martin Owen, Ian Cox -- Multivariate Data Analysis (MVDA) / Claire Beckett, Lennart Eriksson, Erik Johansson, Conny Wikström -- Process Analytical Technology (PAT) / Line Lundsberg-Nielsen, Walkiria S Schlindwein, Andreas Berghaus -- Analytical Method Design, Development, and Lifecycle Management / Joe Sousa, David Holt, Paul A Butterworth -- Manufacturing and Process Controls / Mark Gibson -- Regulatory Guidance / Siegfried Schmitt, Mustafa A Zaman -- Index -- Supplemental Images.