Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Webinar Recording
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.
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.
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 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
- Instrument validation
- The pumping system
- The column
- The detection system
- The Data System
- Method validation
- Precision and the various measures of precision (repeatability, reproducibility, ruggedness, robustness)
- Limits of detection and quantitation, linearity
- Selectivity, interferences, and specificity
- Solution stability
Who will Benefit
Chemists and laboratory assistants who perform HPLC or UPLC analyses under GLP or ISO 17025.
- Laboratory Assistants
- QA Managers and Personnel
- QC Managers and Personnel
- Validation Specialists
- Quality System Auditors
- Regulatory Compliance Associates
Industries who can attend
This 60-minute online course is intended for professionals in the Pharmaceutical, chemicals and petrochemicals industry.
Faculty John C. Fetzer
Founder and Principal,Consultant Fetzpahs Consulting John C. Fetzer has had over 30 year experience in HPLC methods development. He has authored or co-authored over 50 peer-reviewed papers onl iquid chromatography, has served on the editorial advisory boards of the Journal of Chromatography, Analytical Chemistry, and Analytical and Bioanalytical Chemistry.