Validation of Analytical Methods for Biopharmaceuticals: A Guide to Risk-Based Validation and Implementation Strategies

The book contains many new practical tips, tools and case studies that will allow validation scientists and management to make good risk-based decisions during planning, execution and post-implementation changes for all projects. This book is centered on what "sufficient performance" and "suitable for use" really mean for analytical methods. Dr. Krause will also answer the question, how can we measure risk and control this risk using well-designed validation studies. Currently, regulatory guidelines provide only basic guidance for analytical method validation. Dr. Krause's work builds on these basic regulatory guidance documents and provides several detailed validation practices, discussions and case studies on the best-possible strategies to assist readers to make good decisions.