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Articles from Validation Times (June 1, 2001)

1-10 out of 10 article(s)
Title Author Type Words
'Rejection' limits in bioburden tests coming; industry not seen prepared. Flickinger, Bruce 854
Analysis of 483s/EIRs for GMP validation issues. (good manufacturing practice). McCarty, Mark 1253
Blood/Biologics. (Food and Drug Administration's Team Biologics' reports on inspected pharmaceutical companies). 1081
CAPA driving device inspections, leading to big failings - Bulk of device audits flunk due to CAPA. 2548
Industry not finding fungi in monitoring, specialist says. 627
ISO 13485 standard seen setting pace for device QS, not 9001. Seeley, Robert Brief Article 357
Medical Devices. Brief Article 810
Part 11 tricky for device firms; no reprieve offered. Beck, Ellen Brief Article 164
Quality planning needs several facets, exec says. Reid, Ken Brief Article 498
Warning Letter Analysis. Flickinger, Bruce 2339

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