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 |