Monday, March 23, 2009

Amazon Books


Validation plan should include risk prioritization of all company systems, says Acambis quality exec.(Master planning): An article from: Validation TimesValidation plan should include risk prioritization of all company systems, says Acambis quality exec.(Master planning): An article from: Validation Times by Joseph Pickett
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Validation or qualification, the important thing is to show what FDA looks for. (Infrastructure Validation).: An article from: Validation TimesValidation or qualification, the important thing is to show what FDA looks for. (Infrastructure Validation).: An article from: Validation Times by Elisa Ludwig
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Process validation tops warning letter citations in '02; fewer letters issued.(Compliance/Enforcement): An article from: Validation TimesProcess validation tops warning letter citations in '02; fewer letters issued.(Compliance/Enforcement): An article from: Validation Times by Gene J. Koprowski
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Validation, sterility assurance, OOS top regulatory actions in 2005; Able Labs case seen triggering more audits.(Compliance/enforcement): An article from: Validation TimesValidation, sterility assurance, OOS top regulatory actions in 2005; Able Labs case seen triggering more audits.(Compliance/enforcement): An article from: Validation Times
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'Validation Council,' manual seen used successfully at Pharmacia, other firms. (Process Validation).: An article from: Validation Times'Validation Council,' manual seen used successfully at Pharmacia, other firms. (Process Validation).: An article from: Validation Times by Elisa Ludwig
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Validation stops 30% of ANDAs, NDAs in review. (Pre-approval inspections).: An article from: Validation TimesValidation stops 30% of ANDAs, NDAs in review. (Pre-approval inspections).: An article from: Validation Times by Ken Reid
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Cleaning Validation: A Practical ApproachCleaning Validation: A Practical Approach by Gil Bismuth
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The AOAC validation effort for dietary supplements: developing 'gold standard' analytical methods for dietary supplements will level the playing field ... An article from: Nutraceuticals WorldThe AOAC validation effort for dietary supplements: developing 'gold standard' analytical methods for dietary supplements will level the playing field ... An article from: Nutraceuticals World by Mark Roman
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Some validation consultants say lax FDA enforcement part of poor performance by industry.(Software/computers): An article from: Validation TimesSome validation consultants say lax FDA enforcement part of poor performance by industry.(Software/computers): An article from: Validation Times by Eliza Ludwig
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Cleaning validation missing evaluation of detergent residuals at Barr, change control, water system also need work. (Human drugs).: An article from: Validation TimesCleaning validation missing evaluation of detergent residuals at Barr, change control, water system also need work. (Human drugs).: An article from: Validation Times
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Pharmaceutical Validation Documentation Requirements

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