Title:
Good laboratory practice regulations
Author:
Weinberg, Sandy, 1950-
ISBN:
9780849375842
Edition:
4th ed.
Publication Information:
New York : Informa Healthcare, c2007.
Physical Description:
vii, 285 p.
Series:
Drugs and the pharmaceutical sciences ; v. 168
Series Title:
Drugs and the pharmaceutical sciences ; v. 168
Contents:
1. Historical perspective / Jean M. Taylor and Gary C. Stein -- 2. FDA/GLP regulations / Wendell A. Peterson -- 3. Regulation of computer systems / Sandy Weinberg -- 4. The good automated laboratory practices / Gerald J. Whartenby, Paul L. Robinson, and Sandy Weinberg -- 5. Implementing GLPs in a non-GLP analytical laboratory / Stephanie A. Olexa -- 6. Controlling the good laboratory practices inspection process / Carl A. Rockburne and Sandy Weinberg -- 7. Computer systems validation / Sandy Weinberg -- 8. GLP documentation / Mark S. Ferrero -- 9. The FDA's GLP inspection program / George W. James -- 10. The future of the good laboratory practice regulations / Sandy Weinberg.
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