Instrumental liquid chromatography is an analysis widely used to determine purity, 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 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.
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 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.
LEARNING OBJECTIVES
Instrument Validation- The Pumping System
- The Column
- The Detection System
- The Data System
- 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 WILL BENEFIT?
Chemists and Laboratory Assistants who Perform HPLC or UPLC Analyses Under GLP or ISO 17025In 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.
Instrument Validation
- The Pumping System
- The Column
- The Detection System
- The Data System
- 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
Chemists and Laboratory Assistants who Perform HPLC or UPLC Analyses Under GLP or ISO 17025