Course Overview

Stop wrestling with inconsistent chromatograms and uncertain validation protocols. In this immersive two-day workshop, analysts and engineers move seamlessly from theory to hands-on HPLC operation and method-validation execution. By demystifying Reversed-Phase (RP-HPLC), Size-Exclusion (SEC), and Ion-Exchange Chromatography (IEX) while guiding participants through step-by-step validation workflows, the course empowers teams to deliver audit-ready data for biopharmaceutical release testing and stability programs.
 
Why It’s Essential

Improper instrument handling, data-integrity observations, and repeat analyses drain budgets and jeopardize compliance. Equipping staff with a clear understanding of regulatory expectations (21 CFR Part 211) and robust validation practices safeguards revenue, accelerates deviation closure, and protects brand reputation.
 
What Your Team Will Learn

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 chromatography and validation roles.