ch. 1. Introduction to analytical method validation -- ch. 2. Analytical instrument qualification -- ch. 3. HPLC method development and optimization with validation in mind -- ch. 4. Method validation basics -- ch. 5. Robustness and system suitability -- ch. 6. Setting specifications and investigating out-of-specification results -- ch. 7. Validation by type of method -- ch. 8. Analytical method transfer -- ch. 9. Implementing new technology in a regulated environment.