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

John C. Fetzer
Instructor: John C. Fetzer
Date: Friday November 14, 2025
Time:

11:00 AM PST | 02:00 PM EST

Duration: 60 Minutes
Webinar Id: 25068

Price Details

Live Webinar
$150. One Attendee
$290. Unlimited Attendees
Recorded Webinar
$190. One Attendee
$390. Unlimited Attendees
Combo Offers   (Live + Recorded)
$289 $340   One Attendee
$599 $680   Unlimited Attendees

Unlimited Attendees: Any number of participants

Recorded Version: 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 you should 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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