Articles from Validation Times (July 1, 2007)

Title	Author	Type	Words
'Lean' Six Sigma seen helping identify risk in manufacturing, QA.	Riddle, John		424
API firm slapped with 483 for calibration and maintenance of equipment.			1035
Avazzia cited for lack of procedures for design changes.			563
CAPA flaws noted in 12-item FDA write-up.			294
Cordis engineer outlines five-phase approach to using Six Sigma to validate quality system; 'Kaizen' explained.	Riddle, John		529
Crystal Reflections written up for lack of validation procedures.			405
Device firm warned for failing to identify quality problems.			560
Forest Pharma handed a 5-item 483 for faulty lab controls.			287
ImmuCell warned for 'serious' GMP deviations.			114
Part 11 undergoing fundamental change within FDA; focus on integrity, not technology is key.			474
QA failures including OOS trip up DSM Pharma.			725
Sitek receives warning letter for QA flaws.			231
Task force recommends new guidance on quality, risk assessment, safety of nanoscale materials.	Pickett, Joseph		730
Two-leveled risk assessment team advised to examine complaints.	Riddle, John		610