Articles from Validation Times (January 1, 2006)

Title	Author	Type	Words
Approaches exist to deal with regional specifications.	Faden, Mike		584
Banner fails to follow stability program in 6-item 483.	Picket, Joseph		492
Bristol-Myers Squibb ducks 483, despite failure to maintain validation records.	Picket, Joseph		410
CAPAs and quality data cited for Guidant.			139
CAPAs, process analysis and quality records flawed for device firm.			256
Carrington warned for microoganism in mouthwash.			180
CBER guidance on post-approval changes, seen in late '06, to give reprieve to hot-water WFI systems.	Faden, Mike		531
Draft guidance for GMPs in Phase I drug development provides first update since 1991.	Pickett, Joseph		822
Egyptian device firm tripped up by insufficient QS audits and process validation errors.	Pickett, Joseph		672
Final guidance for GMP inspection dispute resolution does not cover PAI issues.	Picket, Joseph		725
LifeScan tripped up by failure to meet specs.			283
Los Angeles-based Chemica receives 4-item 483 for stability test chamber flaws.	Picket, Joseph		421
Normed fails to validate 'with high degree of assurance'.			218
PCR-based test speeds detection of mycoplasma contaminants: Genentech.	Faden, Mike		434
Process controls and calibration checks lacking for Nephron Pharmaceuticals.			288