Complying with the New USP General Chapter on Analytical Instrument Qualification

Live Air Date: Thu, Aug 17, 2017 10:15 AM EDT{LOCAL_TZ}

1 hour  

Event Overview

Implemented in August 2008, USP General Chapter on Analytical Instrument Qualification (AIQ), <1058>, has just been updated and the new general chapter is effective from August 2017.  The evolution of this general chapter to clarify the requirements of the 4Q stages, particularly differences between OQ and PQ, and the inclusion of User Requirements and Software Validation is of global significance because the USP is the only Pharmacopeia that provides guidance on Analytical Instrument Qualification.

Webinar participants will learn:
  • What the new USP general chapter <1058> contains
  • How to comply with the new requirements
  • Why companies need to update SOPs for AIQ now


Presenters


Paul Smith
Global Strategic Compliance Specialist
Agilent Technologies

Paul Smith is a Global Strategic Compliance Specialist at Agilent Technologies. Paul worked in a variety of quality and management roles in the pharmaceutical industry for 17 years, before moving into compliance consultancy work, which he has done since 2002. Paul has an interest in compliance harmonization / collaboration and has been closely involved in the evolution of analytical instrument qualification, contributing to GAMP Good Practice Guides and USP <1058> developments. Within his Agilent role, he monitors regulatory actions for trends / changes and shares this information through publications, presentations and Webinar events.






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