Illustration of regulatory inspector and lab analyst in the laboratory with LC and GC instruments and chromatography software.

2-Part Webinar Series

Five Essentials for Surviving Your Next Laboratory Inspection: A Quality Control Example

OpenLab

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.

Five Essentials for Surviving Your Next Laboratory Inspection: A Quality Control Example

Part 1

Illustration of regulatory inspector and two lab analyst in the laboratory with LC and GC instruments and chromatography software.

In part 1, we will go cover the background on data integrity and a chromatography data system, management involvement in data integrity, qualification of chromatographs, and validation of analytical procedures.

Part 2

A screen shot of OpenLab CDS software in a computer monitor.

In part 2, we will cover the set up of a chromatography data system and sample analysis, peak integration, review and e-signatures, and investigations of out-of-specification (OOS) results and invalidation of OOS results.

Key learning objectives

  • Understand how data integrity plays a role in your inspection
  • Understand and answer the questions being asked
  • Understand the impact of poor analytical decisions
  • Use systems that can help demonstrate data integrity and regulatory compliance
  • Use technical controls to enforce operating procedures

Speakers

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