Even if you have robust quality systems governing your analytical laboratory and a strong data integrity program in place, you may still be nervous about preparing for a regulatory inspection. What will the inspectors want to know? What will they ask? Is your team prepared?
You can ease those fears by attending this two-part webcast. First, we will explain what you should expect during an inspection. Then, we will simulate an inspection to show you, in a realistic scenario, what an inspector might ask, and how you and your team should handle the questions, including when they don’t know all the answers or don’t understand all the questions. We will explain the scope of a data integrity inspection in a regulated laboratory, and our simulation of an inspection of a chromatography data system (CDS) will explain the roles of different people in a multi-person team that includes a laboratory manager and the CDS laboratory administrator.
An Executive Summary of each webinar is also available for download.
