Articles from Validation Times (December 1, 2000)

Title	Author	Type	Words
Analysis of 483s/EIRs for GMP validation issues. (Food and Drug Administration's inspection of good manufacturing practice at some pharmaceutical companies).	McCarty, Mark		1890
Blood/Biologics.			1163
Lab equipment validation - SOPs for HPLC seen important in audits of drug QC labs.	Dechnik, Peter	Brief Article	611
Laboratory controls - GMP requirements seen for importers, pharmacies via law.	Fields, Howard; Reid, Ken	Brief Article	735
Master planning - Cleveland Clinic using master plans to abide by Part 11.	Beck, Ellen		415
Medical Devices. (Food and Drug Administration's inspection of good manufacturing practice at Medex).		Brief Article	810
Quality systems - 'Six Sigma' can gel with QS, even 1978 drug GMPs: expert. (good manufacturing practice, Charles Truby).	Reid, Ken	Brief Article	483
Software validation - Recalls, complaints yield 'sexy 483s,' ex-FDAer contends.	Dechnik, Peter	Brief Article	278
Vaccine shortages abated, but FDA, CDC concerned about '01 outlook. (Food and Drug Administration, Centers for Disease Control and Prevention).	Reid, Ken	Brief Article	683
Warning Letter Analysis.	McCarty, Mark		994