June 2013
Intermediate to advanced
374 pages
7h
English
Content preview from Quality Assurance
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List of tables
| 1.1 | FDA predicate rules for written SOPs | 10 |
| 1.2 | Correspondence between roles and observations | 12 |
| 1.3 | The routine review of life-cycle documents | 16 |
| 1.4 | Fields in typical Notice of Event form | 19 |
| 1.5 | Elements of CAPA | 20 |
| 1.6 | FDA predicate rules for adverse events | 26 |
| 1.7 | FDA predicate rules for complaint files | 28 |
| 2.1 | Illustrative production observations that will be escalated | 39 |
| 2.2 | Illustrative lab observations that will be escalated | 39 |
| 2.3 | Illustrative observations that will be triaged | 40 |
| 2.4 | Reason’s models of human error | 44 |
| 2.5 | Format of final investigation report | 46 |
| 2.6 | Format of investigation summary | 46 |
| 2.7 | Elements of the program logic model | 48 |
| 3.1 | Measuring the complexity of lab tests | 61 |
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I'm always learning. So when I got on to O'Reilly, I was like a kid in a candy store. There are playlists. There are answers. There's on-demand training. It's worth its weight in gold, in terms of what it allows me to do.