Articles from Validation Times (September 1, 2003)

Title	Author	Type	Words
3 to 9 retests for OOS deemed acceptable to FDA, former CDER official says.	Reid, Ken		691
AccuMed gets clean bill of health.			366
Airgas Norpac passes unannounced follow-up audit with flying colors.			391
Cardio Design lacks validation of the design controls for anal sensor, vaginal sensor.			166
CardioCommand hit with validation, verification deviations.			346
Comparability protocols may reduce application submission and filing requirements.	Sami, Tamra		643
Device company addresses quality, validation issues.			301
Edge Biologicals hit with numerous GMP, QS deficiencies.			441
Electrode cable manufacturer fails to establish adequate QA/QC measures, FDA says.			340
FDA cites PPD Development with inadequate assay validation.			308
FDA guidance emphasizes voluntary PAT deployment, but business, political climate may drive industry to move quicker.	Sami, Tamra; Reid, Ken		1260
FDA may rewrite Part 11, but issues final guidance exempting 'legacy computers,' clarifies audit trails.	Gould, Dawn; Sami, Tamra		1091
FDA says Astro insufficiently addressed QS regulation deviations.			375
FDA, EU expecting manufacturers to use CAPA to halt OOS, determine 'root cause'.	Reid, Ken		673
Industry more pleased with newest draft, concerned about conflicts with EU/ISO document.	Sami, Tamra		1301
IVF device maker handed hefty 28-item 483.			536
Ludwig fails to validate processes for gamma irradiation of products.			294