Monday, March 23, 2009

Amazon Books


12-item 483 issued to Yung Shin Pharmaceutical for OOS, multiple validation violations.(Human Drugs): An article from: Inspection Monitor12-item 483 issued to Yung Shin Pharmaceutical for OOS, multiple validation violations.(Human Drugs): An article from: Inspection Monitor
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Guideline on Validation of Analytical Procedures for Pharmaceuticals (Draft 2/94)Guideline on Validation of Analytical Procedures for Pharmaceuticals (Draft 2/94)
Buy new: $28.00
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PhRMA opposes user fees for further FDA enforcement, says talks stalled by lack of commissioner.(Pharmaceutical Research and Manufacturers of America)(Brief Article): An article from: Validation TimesPhRMA opposes user fees for further FDA enforcement, says talks stalled by lack of commissioner.(Pharmaceutical Research and Manufacturers of America)(Brief Article): An article from: Validation Times
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Validation, repeat slips lead to Seatrace warning.(Seatrace Pharmaceuticals warned by FDA)(Brief Article): An article from: Inspection MonitorValidation, repeat slips lead to Seatrace warning.(Seatrace Pharmaceuticals warned by FDA)(Brief Article): An article from: Inspection Monitor
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Checklists, code prompt FDA to dig deeper: consultant.(Food and Drug Administration, inspection of pharmaceutical industry computer systems)(Brief Article): An article from: Validation TimesChecklists, code prompt FDA to dig deeper: consultant.(Food and Drug Administration, inspection of pharmaceutical industry computer systems)(Brief Article): An article from: Validation Times by Peter Dechnik
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Computers, Part 11 trip Enzon; OOS a factor, too.(inspection of Enzon)(Brief Article): An article from: Validation TimesComputers, Part 11 trip Enzon; OOS a factor, too.(inspection of Enzon)(Brief Article): An article from: Validation Times
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GMP Training Package Manual and CD, The FDA Regulations on Part 11, Electronic Records and Electronic Signatures, For Pharmaceutical, Medical Device, Food, ... System Validation and Part 11, Covering FDGMP Training Package Manual and CD, The FDA Regulations on Part 11, Electronic Records and Electronic Signatures, For Pharmaceutical, Medical Device, Food, ... System Validation and Part 11, Covering FD by Daniel Farb
Buy new: $499.95 / Used from: $398.98
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FDA to create drug 'Pharmaceutical Inspectorate,' team audits; PAT advances. (Inspections/PAT).: An article from: Validation TimesFDA to create drug 'Pharmaceutical Inspectorate,' team audits; PAT advances. (Inspections/PAT).: An article from: Validation Times by Tamra Sami
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IPEC rolls out GMP auditing program for excipients.(International Pharmaceutical Excipients Council of the Americas, good manufacturing practices)(Brief Article): An article from: Validation TimesIPEC rolls out GMP auditing program for excipients.(International Pharmaceutical Excipients Council of the Americas, good manufacturing practices)(Brief Article): An article from: Validation Times by Dan Whipple
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PAT is 'emblematic' of new pharmaceutical thinking under 'Critical Path,' Woodcock tells IFPAC.(PAT): An article from: Validation TimesPAT is 'emblematic' of new pharmaceutical thinking under 'Critical Path,' Woodcock tells IFPAC.(PAT): An article from: Validation Times by Joseph Pickett
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