Articles from Validation Times (December 1, 2002)

Title	Author	Type	Words
Abbott hit for failure to validate environmental monitoring system. (Human Drugs).			294
Analyzers found to not have method validation data. (Oxygen).			157
B-D equipment records found deficient in Puerto Rico plant. (Medical Devices).			168
BMS manufacturing singled out for uniformity deficiencies. (Human Drugs).			225
CDC leads effort to increase antibiotic stockpile in case of attack. (Bioterrorism).	Miller, Paula		543
Data management key to solving "GMP paradox". (GMPs).	Sami, Tamra		548
Failure to validate manufacturing nets Best a letter. (Human Drugs).			163
FDA criticized for lacking Part 11 guidance, but boosting enforcement. (Electronic records).	Seeley, Robert S.		553
GMP validation slips become theme in recent Lilly audits. (Human drugs).			777
Lack of CAPA tip of iceberg for Health Care. (Medical Devices).			156
Less FDA audit exposure seen if firms have "corporate compliance program". (Compliance).	Sami, Tamra		408
Medix drops DermaFreeze after compliance efforts prove unprofitable. (Medical devices).			615
Repackager device design specs are unvalidated, FDA states. (Medical Devices).			186
Second inspection has Par redouble violations, compliance efforts. (Human drugs).			704
Unico's revalidation protocols hit in four areas. (Human Drugs).			267
Unrealistic risk management, vague terms plague FDA's aseptic processing paper, industry says. (Aseptic processing).	Miller, Paula		1224