HPLC Analytical Method Development And Validation

🎤 Dr. John C. Fetzer | 📅 Recording Available | 🕒 60 Minutes

DESCRIPTION:

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

The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation of the instrumentation and other associated items of the column, solvents, and other 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 specific analytical methods are method validation and instrument validation. To not do so is a non-compliance in which any data is not usable or reportable.

Areas Covered In The Session:

Instrument validation

The Pumping System
The Column
The Detection System
The Data System

Method Validation

Accuracy
Precision and the various measures of precision (repeatability, reproducibility, ruggedness, robustness)
Limits of detection and Quantitation, Linearity
Selectivity, Interferences, and Specificity
Sensitivity
Solution Stability

Who Should Attend:

Chemist
Laboratory Assistants
QA Managers and Personnel
QC Managers and Personnel
Validation Specialists
Quality System Auditors
Regulatory Compliance Associates