Articles from Validation Times (September 1, 2007)

Title	Author	Type	Words
7 CMC guidance documents withdrawn for non-conformity with FDA's GMP initiative.	Pickett, Joseph		402
Danmar receives warning letter for CAPAs.			362
Device firm written up for CAPAs, quality system procedures.			161
Dirty equipment and CAPAs net 4-item 483.			728
Dornier Medtech cited for undocumented process validation.			246
GMP audit imminent after 6-year inspection gap, states 2007 risk-based model: Gardner.	Pickett, Joseph		497
Improper laboratory controls, validation net 483 for Ivax.			352
IPEC group examining applying principles of validation to non-actives.	Reid, Ken		541
Leiner Health issued letter regarding data manipulation.			584
Management not monitoring quality system cited for North Coast.			237
Medical concepts gets 9-item 483 for CAPAs, unvalidated lab tests.			314
Method validation documentation cited in Kushan letter.			256
Risk-based auditing nets 6% decrease in follow up FDA audits in same year.	Pickett, Joseph		547
Tmed nets 5-item 483 for CAPAs.			256
With recalls numbering 975 to date, FDA relying on ICH Q10 for QbD progress.	Pickett, Joseph		894