Introduction to the Audit Process elearning

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Course Introduction

The course is made up of nine learning modules and is intended to provide an introduction to the audit process.

The course includes

• An understanding of the aims of the audit
• Identifying how to initiate the audit
• An understanding of how to effectively conduct document review
• Preparation for on-site audit activities
• How to perform on-site audit activities
• An appreciation of the requirements of preparing, approving and distributing the audit report
• How to complete an audit and conducting audit follow up
• Identifying trends, performing root cause analysis and considering corrective and preventive action.

Course Author

Louise Handy is now the Director of Handy Consulting Ltd, and has previously held senior positions across the breadth of the drug development and scientific research industry. Originally a research immunologist, she became CEO of a contract clinical research organisation and was Head of Quality & Regulatory Affairs for an injectable pharmaceutical manufacturer. Louise is the current Chair of the RQA and a member of the Institute of Clinical Research and the Chartered Management Institute. She works across all the GxPs, has been an EU QP for Pharmacovigilance, has been responsible for developing guidelines for Good Research Practice and has an international reputation in Good Clinical Laboratory Practice.

Corporate Licences

Multi-user licences for corporate use are also available, please click here for prices and further information.

Course Demo

Click here for demo (website registration/login required).

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