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Book Categories |
1 | Change Is Inevitable - Why? | 1 |
2 | Regulation of Change Control for Drugs and Biologics - U.S. | 15 |
3 | A Regulatory View - EU | 37 |
4 | The Operational Phase | 51 |
5 | The Change Control System | 69 |
6 | Change Control and Computer Systems | 93 |
7 | Case Histories and Anecdotes | 123 |
8 | Projects | 149 |
List of Abbreviations | 165 | |
Glossary | 169 | |
Index | 173 |
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