1. Cleaning objectives -- 2. Cleaning and cleaning agents -- 3. Cleaning methods -- 4. Process parameters in cleaning : part I -- 5. Process parameters in cleaning : part II -- 6. Cleaning cycle development -- 7. Grouping strategies -- 8. Setting acceptance criteria -- 9. Analytical methods for cleaning validation -- 10. Sampling methods for cleaning validation -- 11. Microbial issues in cleaning validation -- 12. Change control and revalidation -- 13. Special topics in cleaning validation -- 14. FDA expectations.