Liquid chromatography is widely used to measure the purity, impurities and degradation products of pharmaceuticals. This 60-minute HPLC analytical method development and validation webinar covers both sides of the validation work that auditors look at.
Most validation effort goes into the method itself, the standard operating procedure. But auditors also examine validation of the instrument and related items such as the column, solvents and other reagents and chemicals.
You'll work through instrument validation, from the pumping system to the data system, and the key method validation parameters, including accuracy, precision, detection and quantitation limits, linearity, specificity and solution stability.
WHY SHOULD YOU ATTEND?
To meet US EPA or FDA requirements, an analytical method has to satisfy many strict requirements, with method validation and instrument validation among the most important. Skipping them is a compliance failure, and the resulting data can't be used or reported.
This training suits chemists and laboratory assistants who run HPLC or UPLC analyses under GLP or ISO 17025.
AREA COVERED
Instrument validation
- The pumping system
- The column
- The detection system
- The data system
Method validation
- Accuracy
- Precision and its measures: repeatability, reproducibility, ruggedness and robustness
- Limits of detection and quantitation, and linearity
- Selectivity, interferences and specificity
- Sensitivity
- Solution stability
LEARNING OBJECTIVES
- Explain why method and instrument validation are both needed to meet EPA or FDA requirements
- Validate the pumping system, column, detection system and data system
- Assess accuracy and the different measures of precision
- Determine limits of detection and quantitation and confirm linearity
- Evaluate selectivity, interferences, specificity and sensitivity
- Check solution stability as part of method validation
WHO WILL BENEFIT?
Chemists and Laboratory Assistants who Perform HPLC or UPLC Analyses Under GLP or ISO 17025
To meet US EPA or FDA requirements, an analytical method has to satisfy many strict requirements, with method validation and instrument validation among the most important. Skipping them is a compliance failure, and the resulting data can't be used or reported.
This training suits chemists and laboratory assistants who run HPLC or UPLC analyses under GLP or ISO 17025.
Instrument validation
- The pumping system
- The column
- The detection system
- The data system
Method validation
- Accuracy
- Precision and its measures: repeatability, reproducibility, ruggedness and robustness
- Limits of detection and quantitation, and linearity
- Selectivity, interferences and specificity
- Sensitivity
- Solution stability
- Explain why method and instrument validation are both needed to meet EPA or FDA requirements
- Validate the pumping system, column, detection system and data system
- Assess accuracy and the different measures of precision
- Determine limits of detection and quantitation and confirm linearity
- Evaluate selectivity, interferences, specificity and sensitivity
- Check solution stability as part of method validation
Chemists and Laboratory Assistants who Perform HPLC or UPLC Analyses Under GLP or ISO 17025
