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Front MatterAbstract - Hi-Res PDF (768 KB) - PDF w/links (1098 KB)
1
Chapter 1. Regulatory SubmissionsAnisa Dhalla, Patricia FritzAbstract - Hi-Res PDF (602 KB) - PDF w/links (624 KB)
65
Chapter 2. Compliance Requirements During the Drug Development ProcessMartin D. Hynes IiiAbstract - Hi-Res PDF (352 KB) - PDF w/links (359 KB)
83
Chapter 3. ValidationJames AgallocoAbstract - Hi-Res PDF (562 KB) - PDF w/links (577 KB)
129
Chapter 4. Validating Analytical Methods for Pharmaceutical ApplicationsRichard F. Meyer, Paul A. WinslowAbstract - Hi-Res PDF (557 KB) - PDF w/links (575 KB)
185
Chapter 5. The Stability Testing ProgramMaria A. GeigelAbstract - Hi-Res PDF (458 KB) - PDF w/links (473 KB)
223
Chapter 6. Computer ValidationTimothy Horgan, Timothy CareyAbstract - Hi-Res PDF (428 KB) - PDF w/links (438 KB)
251
Chapter 7. Compliance Issues Associated with Cleaning in the Pharmaceutical IndustryWilliam E. HallAbstract - Hi-Res PDF (447 KB) - PDF w/links (461 KB)
285
Chapter 8. The Batch RecordTroy FugateAbstract - Hi-Res PDF (430 KB) - PDF w/links (442 KB)
315
Chapter 9. Change ManagementSusan FreemanAbstract - Hi-Res PDF (445 KB) - PDF w/links (456 KB)
347
Chapter 10. The Vendor Qualification ProgramElizabeth M. Troll, Karen L. HughesAbstract - Hi-Res PDF (423 KB) - PDF w/links (431 KB)
373
Chapter 11. Handling Laboratory and Manufacturing DeviationsRobert B. KirschAbstract - Hi-Res PDF (594 KB) - PDF w/links (615 KB)
429
Chapter 12. The Internal Audit ProgramGraham BunnAbstract - Hi-Res PDF (470 KB) - PDF w/links (481 KB)
463
Chapter 13. Preapproval InspectionsMartin D. Hynes IiiAbstract - Hi-Res PDF (468 KB) - PDF w/links (479 KB)
493
Chapter 14. The Impact of Total Quality Performance on ComplianceAbstract - Hi-Res PDF (663 KB) - PDF w/links (681 KB)
553
Chapter 15. International Compliance Issues and TrendsAlan G. MinskAbstract - Hi-Res PDF (420 KB) - PDF w/links (432 KB)
583
Chapter 16. Strategic Planning for Compliance and Regulatory DefensivenessRon JohnsonAbstract - Hi-Res PDF (366 KB) - PDF w/links (377 KB)
605
Chapter 17. Unique and Unprecedented Compliance Challenges in the Biologics ArenaCurtis L. Scribner, Anne P. HoppeAbstract - Hi-Res PDF (497 KB) - PDF w/links (511 KB)
