1. What is validation? -- 2. The history and roots of validation -- 3. Why do we validate? How much does it cost? -- 4. Who is responsible for validation? -- 5. How does validation affect you? -- 6. Validation policy, strategy protocols and the validation report -- 7. What activities support the validation effort? -- 8. What are the consequences of not validating? -- 9. For whom are we validating? -- 10. Preparing standard operating procedures and the validation master plan -- 11. How do we plan and programme validation? -- 12. A lexicon of validation terminology.