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.
Laboratory Controls
Instructor: John Fetzer
Product ID: 507688
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.

Who will Benefit
  • Lab Chemists
  • Lab Managers
  • Lab Technicians
  • Lab Analysts
  • Industries into Compliance Methodology (Biotech, Pharma)
  • Companies into Environmental Compliance or EPA
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  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
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  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Dr. John C. Fetzer has been doing liquid chromatographic method development for over 35 years. His PhD was in studies of various types of chromatography. He has authored or co-authored over 50 papers on LC separations, has served on the advisory boards of the Journal of Chromatography, Analytical Chemistry, and Analytical and Bioanalytical Chemistry. He supervised the Good Laboratory Practices accreditation of a large research chromatography laboratory and has taught numerous short courses on GLP and ISO 17025 compliance.
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