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Validity : 22nd Jul'24 to 01st Aug'24
How to Deal with Bad Results Under GLP
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
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.
Who should attend?
- Chemist
- Laboratory Assistants
- QA Managers and Personnel
- QC Managers and Personnel
- Validation Specialists
- Quality System Auditors
- Regulatory Compliance Associates
Why should you attend?
Instrumental liquid chromatography, either HPLC or UPLC, are common technique in laboratories that is 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). However, validation of the instrumentation and other associated items of columns, 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.
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.