Validation of HPLC/UPLC Methodologies

Attendees will learn more about HPLC/UPLC Methodologies. The focus of most validation work is on the methodology, the Standard Operating Procedure (SOP). 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. This presentation will cover the key elements to have a compliant method.

John C. Fetzer
Instructor:
John C. Fetzer
Duration:
60 Minutes
Product Id:
502968
Access:
6 months

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Price Details
$190 Recorded
$390 Corporate Recorded
Price Detail Options
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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