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Controlling Organic Impurities in Pharma: ICH Q3A/Q3B and FDA Compliance Tactic

Instructor John C. Fetzer
Webinar ID 93164
10 Days Left To REGISTER

Date Friday, November 14, 2025
Time 11:00 AM PST | 02:00 PM EST
Duration 60 Minutes  

Webinar Price Details

Overview

Low-level analysis can be very difficult. Basic issues in both qualitative and quantitative analyses will be described.

Why should you Attend

Trace-level analysis under Good Laboratory Practices or ISO 17025 is quite different when the target analytes are at very low amounts. The effect and requirements for accuracy, precision, selectivity, and other validation requirements are demanded are different than and more difficult to meet than those for higher concentrations. Basic parameters, such as precision and accuracy, are more difficult. Qualitative (identification of a molecule’s structure and identity) can be much more difficult.

Areas Covered in the Session

  • Official guidelines
  • Uncertainty and identification
  • Comparison to standard compounds
  • Issues in accuracy
  • Interferences and matrix effects

Who Will Benefit

  • Laboratory Personnel
  • Quality Officers

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.