Validation of HPLC/UPLC Methodologies

  • Tuesday
  • May
  • 11
  • 2021
Time:
10:00 AM PDT | 01:00 PM EDT
Duration:
60 Minutes
John C. Fetzer Instructor:
John C. Fetzer
Webinar Id:
50518

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Price Details
$149 Live
$299 Corporate Live
$199 Recorded
$399 Corporate Recorded
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Live + Recorded
$299 $348 Live + Recorded
Corporate (Live + Recorded)
$599 $698 Corporate
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Overview:

This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.

Why should you Attend: Instrumental liquid chromatography, either as HPLC or UPLC, are common techniques in laboratories that are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.

The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation of the instrumentation and other associated items of column, solvents, and other reagents and chemicals is also an area of focus in an audit.

For Good Laboratory Practice (GLP) or for ISO 17025 compliance, such methods must meet certain requirements. This presentation will cover the key elements to have a compliant method.

Areas Covered in the Session:

  • Instrument validation
    • The pumping system
    • The column
    • The detection system
    • The Data System
  • Method validation
    • Accuracy
    • Precision and the various measures of precision (repeatability, reproducibility, ruggedness, robustness)
    • Limits of detection and quantitation, linearity
    • Selectivity, interferences, and specificity
    • Sensitivity
    • Solution stability

Who Will Benefit:
  • Chemist
  • Laboratory Assistants
  • QA Managers and Personnel
  • QC Managers and Personnel
  • Validation Specialists
  • Quality System Auditors
  • Regulatory Compliance Associates


Speaker Profile
John C. Fetzer has had over 30 year experience in HPLC methods development. He has authored or co-authored over 50 peer-reviewed papers onl iquid chromatography, has served on the editorial advisory boards of the Journal of Chromatography, Analytical Chemistry, and Analytical and Bioanalytical Chemistry.


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