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Course Introduction

Introduction

The course is made up of six learning modules and covers the background and the granting of authority to managing an audit programme together with its establishment, implementation, monitoring and reviewing and finally opportunities on how to improve an audit programme .

Course Key Points

The course includes:

  • An introduction to understanding the need for an audit programme
  • The granting of authority for managing an audit programme
  • Investigating how to establish an audit programme
  • Understanding how to implement an audit programme
  • Monitoring and reviewing an audit programme
  • Investigating how to improve an audit programme

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 currently the Chair of 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.