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

John C. Fetzer Instructor:
John C. Fetzer 
Friday, November 14, 2025
11:00 AM PST | 02:00 PM EST
60 Minutes
Webinar ID: 503467

More Trainings by this Expert

Price Details
Live Webinar
$149 One Attendee
$299 Corporate Live
Recorded Webinar
$199 One Attendee
$399 Corporate Recorded
Combo Offers
Live + Recorded
$299 $348 Live + Recorded
Corporate (Live + Recorded)
$599 $698 Corporate
(Live + Recorded)

Live: One Dial-in One Attendee

Corporate Live: Any number of participants

Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)

Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)

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.


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