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Validity : 01st Jul'25 to 11th Jul'25
Validation of HPLC/UPLC methodologies
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
Overview of the webinar
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 column, solvents, and other reagents and chemicals is also an area of focus in an audit.
Who should attend?
- Analytical Chemists
- QC/QA Professionals
- Laboratory Managers and Supervisors
- R&D Scientists and Associates
- Regulatory Affairs Professionals
- Compliance Officers
- Validation and Method Development Specialists
- Pharmaceutical and Biotech Manufacturing Staff
- Contract Testing Laboratory Personnel
- Auditors and Inspectors involved in laboratory compliance
- Chemists and laboratory assistants who perform HPLC or UPLC analyses under GLP or ISO 17025
Why should you attend?
Instrumental liquid chromatography, either as HPLC or UPLC, are common techniques in laboratories that do regulatory-compliance work. 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.
In order to meet US EPA or FDA requirements, a method must meet many stringent requirements. The more important of these for 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.
Faculty - Dr.John Fetzer
Dr. John C. Fetzer, PhD offers over 20 years of expertise in Analytical Chemistry, focusing on Polycyclic Aromatic Hydrocarbons, Petroleum and its Products, Chromatography, and UV and Fluorescence Spectroscopy. He offers Analytical Chemistry Consulting Services and Scientific Career Development Consulting services to companies, organizations, and individuals. Dr. Fetzer has over a decade of experience as a supervisor, team leader, trainer, and coach. He has published over 100 peer-reviewed scientific publications, 2 books, and 8 book chapters.
Dr. Fetzer is an American Chemical Society tour speaker, who has participated in over twenty invited lectures at conferences, universities, and government laboratories.