Articles from Validation Times (August 1, 2004)

Title	Author	Type	Words
'Training effectiveness' seen important to FDA, especially in clinical manufacturing.	Ludwig, Elisa		495
Anderson Pharmaceuticals cited for misbranding, water, batch record and packaging issues.			1014
Bayer Healthcare releases non-conforming urine chemistry analyzers for distribution.			447
Cardinal Health develops policy and guidelines to implement new European regulations.	Ludwig, Elisa		504
Diamedix fails to investigate, correct non-conforming product.			244
Experts see European directive as good model for clinical supply rules; Japan changing, too.	Ludwig, Elisa		859
FDAer says record-retention for audits can be in paper, no need for passwords on each system if SOPs dictate.			859
Forthcoming guidance to show gradual GMPs for IND drugs, but also cover starting materials.	Ludwig, Elisa		444
Medical device sterilizers simultaneously cited for validation problems.			339
No 483 for research lab, but validation, HPLC issues noted.			369
Satelec Acteon Group hit with 483 and warning letter for process validation, QA deficiencies.			724
Spinal Concepts fails to adequately validate thoracolumbar systems, vertebral replacement devices.			467
Testing facility cited for GLP violations.			472
Wheelchair equipment not routinely calibrated, inspected, maintained.			409