Overview

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.

Why should you Attend

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

Speaker Profile