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How to Prepare for an Audit as a GxP Inspector

Jennifer Kussauer July 20, 2020 629


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In this episode, you will learn what’s so great about being a GxP auditor and how to prepare well for an audit.

If you are an auditor who is going to audit an internal department or supplier, you must know how to prepare well for the activity. Neglecting the preparation crucial preparation phase can make the audit itself a bad experience, which doesn’t bring value.

Our guest is Jennifer Kussauer, a senior international GxP auditor. Jennifer served as an Associate Director, Head of Audits and Inspections Management at Merck KGaA, Darmstadt, Germany. Now she is an independent QA/QM Consultant with expertise in GCP/GVP/GMP/GDP.

Here are some of the topics we covered in our talk:

💡The Art Behind Being a Great Auditor
💡The Biggest Challenges of an Auditor
💡Why Companies Should Be Happy to Be Audited
💡The Best Thing About Auditing
💡Why the Opening Is So Important for a Successful Audit
💡Knowing the Scope Is the Foundation of the Audit
💡The Most Common Mistakes of Audit Preparations
💡Expert Tips for Junior Auditors on How to Learn Their Standards

 

 

 

 

 

 

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You will learn the framework that will help you reduce the number of repeated and overdue issues in your QMS.

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Jennifer Kussauer

Jennifer Kussauer is a Senior International GxP Auditor, QA/QM Consultant with expertise in GCP/GVP/GMP/GDP. Before becoming an independent consultant, Jennifer served as Associate Director, Head Audits and Inspections Management at Merck KGaA in Germany.

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