Understanding the new revision of USP chapter 1058: Analytical Instrument Qualification

This webinar will discuss the new content of revised USP chapter 1058, will compare with the old version and discuss how to implement it. The approaches for risk based qualification, instrument lifecycle, quality agreements, how to integrate software validation and equipment qualification, how to integrate with GAMP Guide on Laboratory Computerized Systems.

Why Should You Attend:

The first version of USP <1058> has been released in 2008. Since then it has evolved as the golden global standard for analytical instrument qualification, despite of some deficiencies of the first version. For example the industry had difficulties to apply the chapter for systems comprising equipment hardware and computer systems. And there have always been comments about not enough details for the four qualification phases. These deficiencies have been clarified in the new revision with much more details on integrated systems but still some interpretation is required for compliant and efficient implementation.

This seminar will help to understand the differences to the existing version. This seminar will discuss all details and give strategies and case studies for easy implementation.