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Preface | ||
Contributors | ||
Ch. 1 | Historical Perspective | 1 |
Ch. 2 | FDA/GLP Regulations | 23 |
Ch. 3 | EPA and Foreign Country GLP Regulations | 111 |
Ch. 4 | Implementing GLPs in a Non-GLP Analytical Laboratory | 157 |
Ch. 5 | GLPs in an Automated Laboratory | 177 |
Ch. 6 | Computer Systems Validation | 223 |
Ch. 7 | The FDA's GLP Inspection Program | 239 |
Ch. 8 | The GLPs: The Cybernetic Necessity | 257 |
Bibliography | 267 | |
Index | 289 |
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Add Good Laboratory Practice Regulations, Recent changes in the interpretation and enforcement of 21 CFR Part 11 have shifted the focus of Good Laboratory Practice (GLP) regulations to concentrate on the acceptance of electronic signatures, the archiving of data, the security of electronic docume, Good Laboratory Practice Regulations to the inventory that you are selling on WonderClubX
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Add Good Laboratory Practice Regulations, Recent changes in the interpretation and enforcement of 21 CFR Part 11 have shifted the focus of Good Laboratory Practice (GLP) regulations to concentrate on the acceptance of electronic signatures, the archiving of data, the security of electronic docume, Good Laboratory Practice Regulations to your collection on WonderClub |