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Good Laboratory Practice Regulations Book

Good Laboratory Practice Regulations
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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
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Digital Copy
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  • Good Laboratory Practice Regulations
  • Written by author Sandy Weinberg
  • Published by Marcel Dekker Inc, 1995/06/09
  • 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
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Book Categories

Authors

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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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

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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

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