Issues in Calibrations and Accuracy in Method Validation

    /John  /C Fetzerspeaker of Training Doyensinvite
    Speaker: John C Fetzer


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    Duration: 75 Minutes
    Product Code: 50723
    Level: Intermediate
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OVERVIEW

One of the most important concepts and criteria of Good Laboratory Practices is accuracy, how well does a methodology stand in terms of quantifying when compared to an expected value? There are various approaches in calibration and in the use of standards for comparisons. This webinar will cover validation of calibrations and the strengths, weaknesses, and appropriateness of the different types of standards. Without accuracy, a result is not acceptable. There are many issues that have an effect on accuracy and there are many approaches to deal with them. The importance of response, matrix effects, selectivity of identification, and other issues will be covered.

WHY SHOULD YOU ATTEND

Accuracy is one of the most fundamental assessments in regulated analyses and calibration is the means to determine it. The quality, and therefore the acceptability, of accuracy is a large part of an auditor’s review of a methodology. This means that the connection of how amounts are determined to known, accepted, and comparable values is a key. This is often difficult when dealing with new compounds assessed by new methods. Approaches to increase the quality of measurement will be covered.

AREAS COVERED

  • How accuracy is determined in analytical method development and validation
  • What are the various types of standards and what are their strengths and weaknesses
  • Analytical method validation and 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

LEARNING OBJECTIVES

  • Comparison by using standards – the types of standards
  • Traceability and documentation in analytical method development and validation
  • Calibration curves – checks for linearity, when non-linearity happens
  • Spikes, surrogates, and standard addition
  • Monitoring calibrations – slope and intercept

WHO WILL BENEFIT

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

SPEAKER

Years of Experience: 30+ years

Areas of Expertise: Chromatography, Analytical Chemistry and Bioanalytical Chemistry

John C. Fetzer is an expert on petroleum, its composition, the composition of its many products – light hydrocarbon gases (natural gas, methane, liquefied petroleum gas), gasoline, diesel fuel, jet fuel, kerosene, naphtha, mineral and lubricating oils, wax, asphalt, petroleum coke). He is an accomplished analytical chemist and expert in chromatography and molecular spectroscopy (infrared, ultraviolet absorbance, fluorescence, mass spectrometry, and nuclear magnetic resonance spectrometry). In that role he developed several Good Laboratory Practices compliant chromatography methodologies, as well as ones to determine octanol-water partition coefficients and to determine solubilities in water and other solvent systems.

He managed a section comprising 6 chromatography laboratories – over 120 chromatographs and 38 people. These laboratories maintain GLP compliance, including implementation of numerous new methodologies. He has been an instructor in statistics as used in the laboratory and on compliance for well over 25 years.

He is a recognized world-class expert in the chemistry and analysis of the polycyclic aromatic hydrocarbons (PAHs). He has over 100 reviewed publications and numerous book chapters, and authored the books The Chemistry and Analysis of the Large Polycyclic Aromatic Hydrocarbons, J. C. Fetzer, John Wiley and Sons, New York, p. 1-288 (2000) and Career Management for Chemists, Springer-Verlag, Berlin, p. 1 -266 (2004).

He worked for a major petroleum company for over two decades before founding his own consulting company. He has served on the editorial advisory boards of Analytical Chemistry, the Journal of Chromatography, Analytical and Bioanalytical Chemistry (Springer-Verlag), and Polycyclic Aromatic Compounds. The 2005 Erich Clar Award of the International Society for Polycyclic Aromatic Compounds (ISPAC) was given to Dr. Fetzer for his variety of research achievements on the large PAHs. He has served as secretary and president of ISPAC.

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