This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.
For Good Laboratory Practice (GLP) or for ISO 17025 compliance, such methods must meet certain requirements. This presentation will cover the key elements to have a compliant method.
Why Should You Attend:
Instrumental liquid chromatography, either as HPLC or UPLC, are common techniques in laboratories that 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 column, solvents, and other reagents and chemicals is also an area of focus in an audit.For Good Laboratory Practice (GLP) or for ISO 17025 compliance, such methods must meet certain requirements. This presentation will cover the key elements to have a compliant method.
Areas Covered in the Webinar:
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 Will Benefit:
This webinar will provide valuable assistance to all personnel working in a GLP certified laboratory and for those developing methods using HPLC for pharmaceutical analysis, environmental analysis, chemicals, petroleum products and petrochemicals. Employees who will benefit include:- QA Managers
- QC Managers
- Analytical Chemists
- Validation Specialists
- Laboratory Managers and Supervisors
- Regulatory Affairs Personnel
- Quality System Auditors
Course Provider
John Fetzer,
