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Labcompliance News, May 2005

May 07, 2005

FDA Perspective on Laboratory Inspections

Yvonne McKnight, chemist at the FDA Philadelphia gave a presentation at the IVT conference "Laboratory Controls & Compliance" in Dublin on April 11, 2005. More than 120 delegates listened to the presentation entitled: Inspection Issues in the Analytical Laboratory: An FDA Perspective". During the presentation McKnight quoted and discussed FDA regulations and enforcement activities, she gave advice on how to prepare for FDA inspections and reported on recent trends and statistics of inspectional deviations. Highlight of the presentation was a TOP TEN list with 483 inspectional observations. Labcompliance Usersclub members can download the presentation. For preview and ordering, click here. To learn more about FDA inspections click here. To read a summary of the presentation and the 483 citations TOP TEN list click here.

May 2005

New Network Quality Package Version 3.0 Released

The package includes

  • 13 SOPs
  • 3 Gap Analysis
  • 8 Validation Examples
  • IVT Network Qualification Standard, Video presentation
  • 7 NIST guidelines
  • Complete audio seminar: Network Infrastructure Qualification - Introduction and Strategies for Compliance
  • Two years on-line updates
  • >50 FDA predicate rules and guidelines related to networks/computers