The US EPA or FDA requirements
Methods employed to determine purity, the impurities, and the degradation products of pharmaceuticals
Requirements to avoid non-compliance
Importance of few specific analytical methods
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.
Instrumental liquid chromatography is an analysis 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). 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:
Chemists and laboratory assistants who perform HPLC or UPLC analyses under GLP or ISO 17025.
|Recorded + Transcript||$ 303.00|
|DVD + Recorded||$ 313.00|
|DVD + Transcript||$ 313.00|
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