Quality by Design (QbD) for Analytical Methods

Duration: 90 Minutes
There are always certain steps in a method where control is critical either because this step contributes a lot to the overall uncertainty or its uncertainty is more likely to change from common causes. These critical points can be assessed and a monitoring program instituted. This data is then collected and plotted on a control chart. Using Nelson's rules of statistical use of control charts, the individual uncertainties are monitored. This allows for early observation and intervention before a non-compliance occurs.
QbD Analytical Method Development
Instructor: John Fetzer
Product ID: 502373
By looking through a method SOP and with knowledge of the chemistry and instrumentation, certain critical factors can be found. Others may be known from past non-compliances. Each of these factors can be assessed for a way to monitor steady and acceptable performance or times in which changes occur. This is done by measurement of a specific parameter and following that over time by using a control chart. Critical warning factors based upon "Nelson's rules", which themselves are based on statistical probabilities, determines acceptable behavior or a likely deviation. These deviations then are signs that a preventive action is does before there is a non-compliance.

Objectives of the Presentation
  • Understanding uncertainty within the steps of an SOP
  • Knowing how to choose critical steps that can cause a non-compliance
  • Knowing how to choose a monitoring variable
  • Understanding control charts
  • Understanding Nelson's rules
  • Being able to have a trigger for a preventive action
Why Should you Attend
Non-compliance, when results are outside of +/- 3, is a catastrophe that must be avoided. Using knowledge of a method allows for monitoring and preventive actions that can make non-compliance very, very rare. Attend this training to learn Quality by Design (QbD) for Analytical Methods in lab.

Areas Covered
  • How to assess a method SOP to identify critical steps
  • Propagation of errors, past history, and the use of chemistry, physics, and instrumental behaviors to assign criticality
  • Assessing a monitoring variable for each critical step
  • The statistics of variation and the use of a control chart
  • The appropriate Nelson's rules for triggering
  • Preventive actions before non-compliance occurs
Who will Benefit
  • Lab Chemists
  • Lab Managers
  • Lab Technicians
  • Lab Analysts
  • Industries into Compliance Methodology (Biotech, Pharma)
  • Companies into Environmental Compliance or EPA
  • Regulatory affairs/CMC personnel responsible for documenting analytical methods and their acceptability
$375
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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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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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