Monday, March 23, 2009

Amazon Books


CAPAs and validation flaws trip up Levitronix.(Medical devices): An article from: Validation TimesCAPAs and validation flaws trip up Levitronix.(Medical devices): An article from: Validation Times by Joseph Pickett
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Documenting validation key to demonstrate comparability.(Methods/validation): An article from: Validation TimesDocumenting validation key to demonstrate comparability.(Methods/validation): An article from: Validation Times by Tamra Sami
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OOS validation least of problems at Alkermes when agency finds problem with vial rejection on filling line. (Human drugs).: An article from: Validation TimesOOS validation least of problems at Alkermes when agency finds problem with vial rejection on filling line. (Human drugs).: An article from: Validation Times
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Validation handled better by generics, CROs, FDA finds.: An article from: Validation TimesValidation handled better by generics, CROs, FDA finds.: An article from: Validation Times by Ken Reid
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Multiple validation violations result in 26-item 483 for Indian firm.(Human drugs): An article from: Validation TimesMultiple validation violations result in 26-item 483 for Indian firm.(Human drugs): An article from: Validation Times by Joseph Pickett
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Process validation, lack of qualification among quality system failures cited in Alpharma 59-item 483.(Human drugs): An article from: Validation TimesProcess validation, lack of qualification among quality system failures cited in Alpharma 59-item 483.(Human drugs): An article from: Validation Times by Tamra Sami
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Validation process procedures nets 11-item 483 for Electrode Store.(Medical devices): An article from: Validation TimesValidation process procedures nets 11-item 483 for Electrode Store.(Medical devices): An article from: Validation Times by Gale Reference Team
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Systems validation, security needs not dead, though some firms think so. (Electronic records).: An article from: Validation TimesSystems validation, security needs not dead, though some firms think so. (Electronic records).: An article from: Validation Times by Elisa Ludwig
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Roche validation summary provided for unvalidated, hybrid, drug manufacturing. (Blood/Biologics).: An article from: Validation TimesRoche validation summary provided for unvalidated, hybrid, drug manufacturing. (Blood/Biologics).: An article from: Validation Times
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Process validation assurance keys on approach, design, quality and conduct of studies, CBER official says.(CMC/validation): An article from: Validation TimesProcess validation assurance keys on approach, design, quality and conduct of studies, CBER official says.(CMC/validation): An article from: Validation Times by Joseph Pickett
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Pharmaceutical Validation Documentation Requirements

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