Laboratory Controls: Anticipate the Systems Based FDA Inspection
Duration: 90 Minutes
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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.
02/09/2018 11:30 AM02/09/2018 05:30 PMTraining Topic: Laboratory Controls: Anticipate the Systems Based FDA InspectionInstructor: John Fetzer
Objectives of the Presentation
The statistics of control charts
Which rules match common laboratory problems
Effects on accuracy and precision
Choosing symptoms (what auditors may look for)
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.
Who will Benefit
Industries into Compliance Methodology (Biotech, Pharma)