Jump to content

Introduction to the Audit Process elearning

RQA Member: USD ($) 134.00
Non-Member: USD ($) 174.00

Your Price: USD ($) 174.00

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 Good Clinical Practice Auditing - Principles and Practice (24th Jun 2019 - 26th Jun 2019)
C0022 Good Clinical Practice Auditing - Principles and Practice (14th Oct 2019 - 16th Oct 2019)
C0041 Research Quality Assurance for Good Laboratory Practice (24th Sep 2019 - 25th Sep 2019)
C0081 The Auditing Course (18th Jun 2019 - 19th Jun 2019)
C0082 The Auditing Course (1st Oct 2019 - 2nd Oct 2019)
C0211 Audit Programmes and Risk Assessment (9th Oct 2019)
C0352 Practical Pharmacovigilance Auditing (1st Oct 2019 - 3rd Oct 2019)
C0421 Advanced Auditing Skills: Audit Analysis and Reporting (11th Sep 2019 - 12th Sep 2019)
C9011 Introduction to Computer Systems Validation (2nd Apr 2019 - 3rd Apr 2019)
C9023 Good Clinical Practice Auditing - Principles and Practice (4th Mar 2019 - 6th Mar 2019)
C9042 Research Quality Assurance for Good Laboratory Practice (2nd Apr 2019 - 3rd Apr 2019)
C9083 The Auditing Course (5th Feb 2019 - 6th Feb 2019)
P01 Introduction to Computer Systems Validation
P02 Good Clinical Practice Auditing - Principles and Practice
P04 Research Quality Assurance for Good Laboratory Practice
P08 The Auditing Course
P21 Audit Programmes and Risk Assessment
P41 Advanced Auditing Skills: Audit Planning and Performance
P42 Advanced Auditing Skills: Audit Analysis and Reporting

Webcasts

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

eLearning Products

Introduction to Managing an Audit Programme elearning

Share