Articles from Validation Times (February 1, 2001)

Title	Author	Type	Words
'Knowledge base' may help CDER identify, degradants, contaminants.	Flickinger, Bruce	Brief Article	427
47% of biologic 483s cite process faults; validation in retro urged.	Lawrence, Terry		588
510(k) Summaries.		Brief Article	138
Analysis of 483s/EIRs for GMP validation issues : Human Drugs Contract Pharmacal hit for OTC drug validation.	McCarty, Mark		1150
Change in cleaning method trips endosseous device firm.		Brief Article	136
Cleaning validation cited at Toll Compaction plant.		Brief Article	208
E-mail SOPs and validation of those procedures advised.	Fields, Howard		805
FDA citing poor 'log off' SOPs under Part 11.	Dechnik, Peter	Brief Article	527
FDA faults reprocessor for poor EtO design, validation.		Brief Article	324
General Device/Evaluation Documents.		Brief Article	148
HIV test kit repackager cited for document control.		Brief Article	987
Lack of internal audit for two years snares Danplex.		Brief Article	204
Medtronic's input V&V fails design control audit.		Brief Article	462
Pharmacia's computers hit at API, finished dose plants.		Brief Article	535
Process guide for devices an aid for master planning.	Lawrence, Terry		827
Software validation gets thumbs down at Ultralite.		Brief Article	304
Validate LIMS via vendor's quantity of clients, but off site.	Dechnik, Peter	Brief Article	180