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HPLC Analytical Method Development and Validation

Master HPLC instrument and method validation to meet US EPA and FDA requirements for pharmaceutical analysis.

4.8(0 reviews)
1 hourWednesday, June 17, 2026
Dr. John C. Fetzer

Instructor

Dr. John C. Fetzer

HPLC Method Development Expert & GLP Compliance Specialist

What You'll Learn

Validate HPLC instrumentation: pumping system, column, detection system, and data system
Apply method validation principles: accuracy, precision, linearity, and selectivity
Understand repeatability, reproducibility, ruggedness, and robustness in validation
Determine limits of detection and quantitation for pharmaceutical methods
Assess solution stability and ensure data integrity for FDA/EPA compliance
Avoid non-compliance that renders analytical data unusable or non-reportable

About the event

Instrumental liquid chromatography is an analysis technique widely used to determine purity, impurities, and degradation products of pharmaceuticals.

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

In order to meet US EPA or FDA requirements, a method must meet many stringent requirements. The more important of these are method validation and instrument validation. Failure to do so is a non-compliance in which any data is not usable or reportable.

Code: FDB2324

Curriculum

The Pumping System — Qualification & Verification
10 min
Column & Detection System Validation
10 min
The Data System — Audit Trail & Integrity
8 min

Requirements

  • Basic understanding of laboratory instrumentation
  • Experience in pharmaceutical or analytical chemistry environments
  • Familiarity with FDA or EPA regulatory requirements is helpful

Who Should Attend

Chemists, Laboratory Assistants, QA Managers and Personnel, QC Managers and Personnel, Validation Specialists, Quality System Auditors, and Regulatory Compliance Associates.

Areas Covered

Instrument validation — pumping system, column, detection, data system
Accuracy and all measures of precision in method validation
Limits of detection and quantitation, linearity
Selectivity, interferences, and specificity
Sensitivity and solution stability
US EPA and FDA method validation requirements

Meet Your Instructor

Dr. John C. Fetzer

Dr. John C. Fetzer

HPLC Method Development Expert & GLP Compliance Specialist

Dr. John C. Fetzer has been doing liquid chromatographic method development for over 35 years. His PhD was in studies of various types of chromatography. He has authored or co-authored over 50 papers on LC separations, has served on the advisory boards of the Journal of Chromatography, Analytical Chemistry, and Analytical and Bioanalytical Chemistry. He supervised the Good Laboratory Practices accreditation of a large research chromatography laboratory and has taught numerous short courses on GLP and ISO 17025 compliance.

PhD Chromatography50+ Published PapersGLP Accreditation ExpertISO 17025 Trainer

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The recording is available to purchase.

Single Recording

Recording (1 viewer)

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Event Details

Format

Live Webinar

Duration

1 hour

Certificate

Included

Date

Wednesday, June 17, 2026

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