The contents: Introduction - Macromolecular Validation - Physico--chemical Method - Control of Bioanalytical Methods - Validation of Pharmaceutical Processes - Validation of Cell-based Processes - Distribution Management Validation - Steam Sterilization - Aseptic Processing - Compliance and Validation - Validation Planning and Reporting - Computer System Validation - Tonicity - Validating Legacy Systems - Quality System Management - Optimization Methods - Validation of a LIMS System - Medication Errors - New Strategies for Target Identification - Metabonomics - Future Directions.