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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.
Why you should 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 Session:
- 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 is this course for?
- Laboratory Assistants
- QA Managers and Personnel
- QC Managers and Personnel
- Validation Specialists
- Quality System Auditors
- Regulatory Compliance Associates
Questions and answers
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Hi there,is this a written format course please?kind regards
Hello Costa, The is a webinar conducted on WebEx. You will be accessing the audio along with the power point presentation. Regards, NetZealous LLCThis was helpful. Thank you for your feedback.
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