1. Regulatory submissions
2. Compliance requirements during the drug development process
3. Validation: A new perspective
4. Validating analytical methods for pharmaceutical applications: A comprehensive approach
5. The stability testing program
6. Computer validation: A compliance focus
7. Compliance issues associated with cleaning in the pharmaceutical industry
8. The batch record: A blueprint for quality and compliance
9. Change management: A far-reaching, comprehensive, and integrated system
10. The vendor qualification program
11. Handling laboratory and manufacturing deviations
12. The internal audit program: A quality assessment
13. Preapproval inspections: The critical compliance path to success
14. The impact of total quality performance on compliance
15. International compliance issues and trends
16. Strategic planning for compliance and regulatory defensiveness
17. Unique and unprecedented compliance challenges in the biologics arena