New USP 1058 Analytical Instrument Qualification Regulations: What the 2017 Requirements Mean and How to Comply
Introduced in August 2008, USP General Chapter on Analytical Instrument Qualification (AIQ), <1058> was unchanged for 9 years. During 2017, the USP implemented two separate updates to <1058> (in August and December). Given that the USP is the only major pharmacopeia with a chapter dedicated to AIQ, changes to <1058> are of global significance. The 2017 updates demonstrate the evolution of USP thinking on AIQ, and laboratories must review the changes very carefully or risk non-compliance. For example, the 2008 version of USP <1058> does not mention User Requirements, but in the 2017 version, an instrument cannot be qualified without a User Requirement Specification (URS).

This webcast has been designed to provide deep insight into the <1058> changes, help laboratories understand its significance, and provide a structured approach of how laboratories can comply.

Address the Paradigm Shift in Regulatory Inspections
The term “FDA audit” can trigger many responses, including dread and panic. It also raises many questions. What triggers a regulatory audit? How has the FDA changed its auditing strategy and what are they focused on? What systems are likely to get inspected? In addition to answering these questions, this webcast will focus on ensuring data integrity in an analytical laboratory. Join us to learn from Humera Khaja, Agilent’s software compliance expert with nearly a decade of regulated software experience.