Effective Handling of Issues in Calibrations and Accuracy under GLP

Accuracy, the ability of a methodology to give results within acceptable limits when compared to known values, is a fundamental and key requirement. Calibration is the most common approach to obtain accuracy.

Accuracy requires a comparison to a validated material. The level of confidence depends on traceability, a chain connecting the samples of interest all the way to the specific metric standards. This can be a complex task that can raise doubts in an auditor. There are different situations for the use of each of the standards of the various types. How to access validity is key.

In calibration, fundamental reliance on the linearity of response make proof of linearity important. This is more involved than only obtaining a linear regression factor or correlation coefficient. Once proven, though, calibrations can change with various factors. Monitoring calibration behavior and using that to maintain or even improve a methodology can be very useful.

Areas Covered in the Session :

  • How accuracy is determined
  • What are the various types of standards and what are their strengths and weaknesses
  • The importance of traceability
  • Calibration curves – what are the important criteria? Linearity versus nonlinearity, slope, intercept and what they mean
  • Matrix effects and how to deal with them
  • Using calibration data to monitor performance
Who Should Attend:

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

FDB3462

Dr. John C. Fetzer

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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