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Laboratory Controls: Anticipate the Systems Based FDA Inspection - Webinar

  • ID: 4455238
  • Webinar
  • February 2018
  • Region: Global
  • 90 Minutes
  • Online Compliance Panel
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The major metrics in laboratory work under GLP are driven by statistics. The sole test usually is only the avoidance of a 3-sigma data point. But the statistics can be used to monitor performance with other statistical criteria that catch problems before there is an out of compliance event. The use of these will be covered, along with examples and explanations that relate to real laboratory problems that could lead an auditor to find a laboratory to be out of compliance.

Objectives of the Presentation
- The statistics of control charts
- Nelson's Rules
- Which rules match common laboratory problems
- Effects on accuracy and precision
- Choosing symptoms (what auditors may look for)
- Getting started
- Continuous improvements through monitoring

Why Should you Attend?

Laboratory operations should be under control so that problems are seen early and corrected before an incident occurs. Know how to do this and what things should be monitored can improve the operation sufficiently so that many operational issues never become unacceptable. This maintains smooth laboratory operations without the disruptions of having to find root causes, stopping of the operation, and revalidation.

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  • Lab Chemists
  • Lab Managers
  • Lab Technicians
  • Lab Analysts
  • Industries into Compliance Methodology (Biotech, Pharma)
  • Companies into Environmental Compliance or EPA
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