Articles from Validation Times (December 1, 1999)

1-27 out of 27 article(s)

Title	Author	Type	Words
'SQA' suggested for software subset; Part 11 facet noted.	Van Wagner, Lisa	Brief Article	887
Abbott sterilization, WFI for parenterals draw letter.		Brief Article	191
Alaris told to do 7 audits til 2002; firmware faulted.		Brief Article	245
Apheresis Technologies' EtO, software validation hit.		Brief Article	142
Calypte cited for autoclave, computer validation faults.		Brief Article	267
CAPA validation slapped on Baxter, BioWhittaker, Biopool.		Brief Article	821
Catalytica hit for not having enough validation personnel.		Brief Article	398
Chemrite, Fabre audits show GMP dearth at OTC drug firms.		Brief Article	367
Contract labs WIL Research, Bioscience get GMP lesson.		Brief Article	425
FDA says Diasol should have used AAMI's LAL methodology.		Brief Article	225
GE-Marquette EIR cites software change errors.		Brief Article	480
Gensia Sicor chooses not to reply to some 483 items.		Brief Article	684
How you thief and sample drugs seen determining BUA.	Reid, Ken; Porter, KT	Brief Article	859
IDEC, Medeva audits highlight bioburden, cleaning citations.		Brief Article	579
Major device reprocessor slapped for EtO validation.		Brief Article	497
Management role becoming key in 'Team Biologics'.	Reid, Ken	Brief Article	799
OOS components, OTS software subject of Synthes warning letter.		Brief Article	248
Peninsula's cleaning, washing of HIV-1 component are noted.		Brief Article	201
Preconfigured SAP systems seen speeding validation (1).	Dechnik, Peter	Brief Article	341
Preconfigured SAP systems seen speeding validation (2).	Dechnik, Peter	Brief Article	711
Process, cleaning validation, stability hit OTC drug maker.		Brief Article	292
Production qualifications, sterilization hit at Septodont.		Brief Article	273
Sunsoft's lenses subject to validation scrutiny.		Brief Article	416
Synagis maker's team audit homes in on depyrogenation.		Brief Article	597
Validation master plan at C&M Pharmacal faulted.		Brief Article	199
Validation plans touted for water, but SOPs needed.	Dechnik, Peter	Brief Article	578
Warning Letter Analysis.	McCarty, Mark		31