Everyone in a laboratory under compliance knows about 3-sigma out-of-control issues. Can the operation be monitored to avoid these? How?
This webinar will cover the basic statistics of compliance and non-compliance and how to use a statistical approach to monitor the operation to ensure that it is under control and to see when a problem is arising, but before it is outside of 3-sigma.
Many problems that arise in an analysis result from causes that start small and grow over time. Others result from an unplanned change in a procedure or the performance of an instrument.
These manifest themselves into changed patterns in certain measurable variables. The use of statistical methods to assess and monitor certain variables will be covered, highlighting the predictable patterns.
Learning Objectives:
- Basic statistics of compliance and non-compliance
- Control Charts
- Nelson's Rules
- Which Nelson's Rule describes common occurrences in the laboratory?
- Examples
Why Should You Attend:
Data quality and compliance to a required level of performance are measured by statistical tools. Usually in compliance there is a very heavy weighing towards only 3-sigma deviations. But statistics gives much more than that. There are other signs that being "out of control" is a building situation. These other statistical patterns can be used to trigger preventive actions without the dire consequence of non-compliance.
Instructor
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.