Good laboratory practice regulations 4th ed
- نوع فایل : کتاب
- زبان : انگلیسی
- مؤلف : Sandy Weinberg
- ناشر : New York : Informa Healthcare
- چاپ و سال / کشور: 2007
- شابک / ISBN : 9780849375835
Description
Contents Preface . . . . iii Contributors . . . . vii 1. Historical Perspective . . . . . . . . . . . . . . . . . . . . . . 1 Jean M. Taylor and Gary C. Stein 2. FDA/GLP Regulations . . . . . . . . . . . . . . . . . . . . . 25 Wendell A. Peterson 3. Regulation of Computer Systems . . . . . . . . . . . 111 Sandy Weinberg 4. The Good Automated Laboratory Practices . . 131 Gerald J. Whartenby, Paul L. Robinson, and Sandy Weinberg 5. Implementing GLPs in a Non-GLP Analytical Laboratory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151 Stephanie A. Olexa 6. Controlling the Good Laboratory Practices Inspection Process . . . . . . . . . . . . . . . . . . . . . . . 167 Carl A. Rockburne and Sandy Weinberg v 7. Computer Systems Validation . . . . . . . . . . . . . . 193 Sandy Weinberg 8. GLP Documentation . . . . . . . . . . . . . . . . . . . . . . 223 Mark S. Ferrero 9. The FDA’s GLP Inspection Program . . . . . . . . 241 George W. James 10. The Future of the Good Laboratory Practice Regulations . . . . . . . . . . . . . . . . . . . . . 259 Sandy Weinberg Index . . . . 271
