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Introduction to the Audit Process elearning

RQA Member: USD ($) 133.00
Non-Member: USD ($) 173.00

Your Price: USD ($) 173.00

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.


Recommended Products

Booklets

A Monitor’s Guide to Investigator Site Audits Booklet
Guide to the Role and Responsibilities of GLP Management Booklet
Hosting an External GLP Inspection Booklet

Courses

C0021 GCP Auditing - Principles and Practice (24th Jun 2019 - 26th Jun 2019)
C0081 The Auditing Course (18th Jun 2019 - 19th Jun 2019)
C9023 GCP Auditing - Principles and Practice (4th Mar 2019 - 6th Mar 2019)
C9042 Research Quality Assurance for GLP (2nd Apr 2019 - 3rd Apr 2019)
C9083 The Auditing Course (5th Feb 2019 - 6th Feb 2019)
C9211 Audit Programmes and Risk Assessment (28th Nov 2018)

Webcasts

Webcast - Audit Programmes: The Basics
Webcast - Where Does Audit End?

eLearning Products

Introduction to Managing an Audit Programme elearning

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