1. Introduction
2. Technology transfer and the climate of change
3. Quality systems structure and a maximum quality environment
4. Validation
5. Good manufacturing practices
6. Process control via numerical means
7. Product verification and the role of qualified personnel
8. In-process and on-process QC testing and control
9. Applications of QA to new medicinal products and new chemical entities formulation
10. New products manufacturing
11. Questions and problems
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