Articles from Validation Times (November 1, 2002)

Title	Author	Type	Words
Aseptic processing guide on hold til after CBER/CDER review merger. (Environmental monitoring).	Travis, Phil W.		1078
BECL backing off on non-510(k) cleared clients. (Medical devices).			650
Blood bank's reshuffling of paperwork hopes to streamline operation. (Blood & Biologics).			685
Codonics does not adequately address unvalidated CAPA, FDA. (Medical Devices).			267
Final BACPAC II guidance not seen til '04; FDA gets few BACPAC I submissions. (APIs/Impurities).	Travis, Phil W.		829
Firms advised to put own 'stamps' on lots to thwart counterfeiting. (Counterfeiting/packaging).	Sami, Tamra		1132
Letter triggers recall for compounding pharmacy. (Human Drugs).			178
Nitro patch maker passes with draft SOPs, retained samples within specs. (Human drugs).			621
Red Cross validation and QA/QC leaves much to be desired, FDA said. (Blood & Biologics).			617
Scooter manufacturer hit with laundry list of QS violations. (Medical Devices).			120
Stability lapses top list of woes at Unit Dose. (Human Drugs).			148
Team Biologics evaluation, e-records policy under GMPs seen completed by February. (GMP Initiative).	Stokes, Erica		957
Timing is everything? Checking computer times not bad idea under new guidance. (Electronic records).	Stokes, Erica		885
Uncertified anti-fungus oil, labeling sends OTC firm to clean up act. (Human drugs).			567
Unvalidated deionization tank process nets MPW a letter. (Medical Devices).			140
Validation of tissue sterilization at South Texas concerns agency. (Blood & Biologics).			151