Course Description:United States Pharmacopoeia (USP) has two General Chapters summarizing the lifecycle approaches and requirements to ensure data quality by demonstrating metrological (<1058>) and procedural integrity (<1220>).United States Pharmacopoeia (USP) General Chapter <1058> on Analytical Instrument Qualification (AIQ) is undergoing a revision process which intends to enhance the current version to a fully lifecycle approach and support General Chapter <1220> on Analytical Procedure Lifecycle. General Chapter <1058> is intended to provide a framework establishing ‘fitness for intended use’ of instruments and systems for use within analytical procedures generating results which are ‘fit for intended purpose’ in accordance with General Chapter <1220> for establishing compliance with the standard monographs of the USP.
Who should participate:
Instrument and system manufacturers, industry end users (such as pharmaceutical Industry research and development laboratory staff, QC laboratory staff, metrology groups staff in centralized laboratories), contract research and development and contract pharmaceutical manufacturers laboratory staff and related functions staff, industry associations and groups as well as regulators, Analytical Chemistry and Pharmaceutical Science graduate students and postdocs. Analytical Chemistry and Pharmaceutical Sciences facultyValidation and metrology engineers, staff and managers, independent consultants
Access Duration:
Access to this course expires 6 months from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
Speaker
Christopher Burgess
USP GCCA Expert Committee Member
M.Sc. & PhD in analytical chemistry from Loughborough University