HPLC Essentials: From Fundamentals to Method Validation

Level

Intermediate

Prerequisites

Participants would benefit from basic previous experience with analytical methods and techniques. An introductory understanding of HPLC systems is an asset to make the most out of this course. Please contact us if you are uncertain whether you meet these prerequisites.

Format

On-site, practical, including essential theory

Duration

2 days

Cost

$1,881

Overview

High performance liquid chromatography (HPLC) is a critical analytical method for in-process analytics and quality control in biopharmaceutical manufacturing. HPLC systems are complex to set up and operate. In this immersive two-day course, participants move from theory to hands-on HPLC operation and method-validation execution. By demystifying reversed-phase (RP-HPLC), size-exclusion chromatography (SEC), and ion-exchange chromatography (IEX), while guiding participants through step-by-step validation workflows, the course equips them to deliver audit-ready data for biopharmaceutical manufacturing applications, including in-process analytics, release testing and stability programs.

Why It’s Essential

Improper instrument handling, data-integrity observations, and repeat analyses are common sources of laboratory investigations, cost overruns and inspection findings. Equipping personnel with a clear understanding of regulatory expectations (21 CFR Part 211) and robust validation practices maximizes operational efficiency, accelerates deviation closure, and protects brand reputation.

Learning Objectives

• Hands-on instrument set-up, troubleshooting, and maintenance for modern HPLC systems

• Application of RP-HPLC, SEC, and IEX to characterize biopharmaceutical products

• Integration of UV and fluorescence detection along with mass spectrometry to expand analytical capability

• Design and execution of instrument qualification (IQ/OQ/PQ) and method validation studies aligned with ICH Q2 (R1) and USP <1225>

• Data-integrity best practices and documentation strategies that withstand audits by regulatory agencies

Who Should Attend

Laboratory technicians, scientists, method developers, and QA/QC professionals in the biopharmaceutical sector—whether entry-level or experienced—who are responsible for analytical development, routine testing, or transitioning into analytical laboratories or validation roles.

Participants who successfully complete a theoretical assessment will receive a certificate of completion.