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[FONT=Arial, Helvetica, sans-serif][SIZE=+1]Analytical Instrument Qualification (AIQ)
NEW USP DRAFT GUIDANCE <1058>
[SIZE=+1]HOW WILL IT AFFECT YOU?[/size]
[SIZE=-1]LIVE WEBCAST: WEDNESDAY, 20 JUNE 2007[/size]
Time: 16:00 UK; 17:00 Mainland Europe
[SIZE=-1][COLOR=#0000ff]REGISTER FREE HERE
[SIZE=1]Note: This is an international webcast and spaces are limited; reservations are on first-come-first-serve basis [/size]
[left]Analytical instrument qualification is the foundation for method validation, calibration, system suitability and other quality control checks. The overall goal is valid analytical measurement! The USP has developed a draft chapter for analytical instrument qualification (AIQ) that firmly places AIQ as a required quality control process. It is well known that FDA inspectors require firms to follow USP standards and procedures. Therefore pharmaceutical companies in the US and elsewhere are advised to prepare - before the standard becomes effective. [/left]
CHAT LIVE WITH INDUSTRY EXPERTS!
Editor in Chief
BioPharm International magazineLudwig Huber, Ph.D.
Agilent TechnologiesSurendra K. Bansal, Ph.D.
Non Clinical Drug Safety
Hoffmann-La Roche, Inc.LEARN WAYS TO IMPLEMENT THE AIQ CHAPTER
AND REDUCE OVERALL QUALIFICATION COSTS
•FDA and other regulations about analytical instrument qualification•Roles and responsibilities: QA, manufacturer, user•Most common inspection problems•Requalification after equipment changes (move, repair, firmware/hardware upgrade)•The background of the USP standard•What documents should be available for the FDA•AIQ and its relation to method validation, system suitability testing and quality control checks•Recommendations for cost effective implementation•USP’s scope and approach for qualification•Access to valuable reference materials: presentations and publications•Purpose and contents of AIQ: DQ, IQ, OQ, PQ •Recommendations for firmware and software validationREGISTER NOW!
• Live Q&A
• Download of speaker presentations
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