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Articles from Validation Times (October 1, 2000)

1-11 out of 11 article(s)
Title Author Type Words
'Comparability protocols' touted as time-saving tools. Beck, Ellen Brief Article 546
Analysis of 483s/EIRs for GMP validation issues. McCarty, Mark Statistical Data Included 1341
Blood/Biologics. Brief Article 764
FDA would like diagnostic test, but validation still key. Fields, Howard Brief Article 820
Medical Devices - Critical Disposables cited for design control faults. Brief Article 533
Problems with biologics persist despite FDA rules. Fields, Howard Statistical Data Included 1036
Quality systems - Risk analysis seen benefitting firms in recall situations. Reid, Ken Brief Article 574
Reworks/blending FDA drafting reprocessing, reworking and blending guidance. Beck, Ellen Brief Article 367
Suggestions offered on post-approval validation actions. Beck, Ellen Brief Article 568
Validation master plans - Lapses in records seen as bug-a-boo in FDA inspections. Dechnik, Peter Brief Article 367
Warning Letter Analysis. 2087

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