Instrumental Issues in the Validation of HPLC/UPLC methodologies

OVERVIEW Instrumental liquid chromatography is an analysis 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. Not do so, is a non-compliance in which any data is not usable or reportable. AREAS COVERED • Instrument validation o The pumping system o The column o The detection system o The Data System • Monitoring for Quality WHO WILL BENEFIT Chemists and laboratory assistants who perform HPLC or UPLC analyses under GLP or ISO 17025. LEARNING OBJECTIVES In... Read more

OVERVIEW Instrumental liquid chromatography is an analysis 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. Not do so, is a non-compliance in which any data is not usable or reportable. AREAS COVERED • Instrument validation o The pumping system o The column o The detection system o The Data System • Monitoring for Quality WHO WILL BENEFIT Chemists and laboratory assistants who perform HPLC or UPLC analyses under GLP or ISO 17025. LEARNING OBJECTIVES Instrumental liquid chromatography, either as HPLC or UPLC, is 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. For more detail please click on this below link: http://bit.ly/2f5mWMs Email: support@trainingdoyens.com Toll Free: +1-888-300-8494 Tel: +1-720-996-1616 Fax: +1-888-909-1882