| 1. Consumer Expectations | 9. Personnel Responsibilities |
| 2. Food and Drug Legislation | 10. Calibrations |
| 3. GMP Regulations | 11. Batch & Master Records |
| 4. Personal/Company Impact | 12. Documentation Practices |
| 5. Regulators : Mandate, Structure | 13. Errors/Mistakes/Deviations |
| 6. Standard Operating Procedures | 14. Packaging and Labeling |
| 7. Pharmaceutical Organization | 15. The Inspection |
| 8. Buildings, Equipment and Sanitation | 16. Inspections and Audits |