Jump to content

The Auditing Course

Course Information

This course is specifically designed to develop and refine personal skills in the planning, performance and reporting of audits.

The course applies to all types of audit and develops the concepts and learning delivered in the RQA’s research quality assurance courses; ‘Research Quality Assurance for Good Laboratory Practice’, ‘Good Clinical Practice Auditing – Principles and Practice’ and ‘Good Manufacturing Practice for Investigational Medicinal Products’.

The course is applicable to any area of regulated research and development. It is particularly valuable where there is a quality system requirement for audit. In order to gain maximum benefit from the course it is recommended that participants have personal experience of audit.

Benefits include improved

  • Organisation of the audit programme to maximise its contribution to quality
  • Audit planning and conduct
  • Effectiveness in communicating audit outcomes
  • Corrective and preventive action

This course is structured to encourage delegates to

  • Discuss and develop ideas
  • Solve problems
  • Exchange information

A major feature of the course is a series of practical workshops. Working in small syndicate groups, delegates will be able to put into practice the skills learned during the lectures.

Course Tutors

Andrew Waddell
Managing Director, TMQA 

Beverley Mehentee
Director, Wider Perspectives Ltd

David Weller
Consultant

Recent Feedback

"...they were all equally brilliant tutors. they all bought their own interpretation of fun to the course to help you relax and ... they showed real enthusiasm for what they do which makes it all the more interesting to listen to their experiences and knowledge because they have the passion."

Course Material

Following requests from attendees of previous RQA events we are pleased to offer course material in PDF format for delegates attending this course. 

The advantages of this include

  • Ability for delegates to keep material on a mobile device
  • Ability to review material at any time pre and post course
  • Environmental benefits – less paper being used per course

The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions.

Additional Requirement
(not included in course fees)

Accommodation is available at Madingley Hall for the dates of the course. If you wish to book alternative dates please specify in the ‘accommodation requirements’ box when making your booking and we will check availability with Madingley Hall.

Course Programme

Day 1

8.45 Registration
9.00 Welcome and Course Objectives
9.10 What is ‘Audit’?
Delegates explore the range of audits which they have experienced and define the purpose of each audit type
9.30 Audits and Their Purpose
The concepts of quality assurance, quality control, quality management and audit are discussed
10.30 Break
10.45 Audit Planning
The requirements for an effective audit programme and individual audit plans
11.30 Workshop 1 – Getting the Audit Started
Planning for the audit
12.25 Workshop 1 - Feedback
12.45 Lunch
13.30 Workshop 2 – Getting the Audit Started
Arranging the opening meeting
13.50 Workshop 2 – Feedback
Audit Initiation
Review and discussion of the role of the opening meeting
14.25 Auditing Techniques (1) – Data and Documentation
Techniques for the conduct of data and report audits are investigated
14.55 Break
15.10 Workshop 3 – Data and Documentation Audit
Conducting an audit of a data package and supporting documentation
17.30 Close of day

Day 2

9.00 Auditing Techniques (2) – The People
Getting pertinent information from the auditee
9.45 Live Audit Role Play
Auditor and auditee behaviours are explored and strategies developed for successful audit interactions
10.15 Break
10.35 Audit Closing Meeting
An exploration of audit closing meetings
11.00 Workshop 4 – Audit Observations and Preparing for the Closing Meeting
Reviewing and categorising your observations and getting ready to present your case
11.45 Workshop 4 - Feedback
12.30 Audit Reports
The content and distribution of an effective audit report are investigated and the importance of effective written communication is discussed
13.00 Lunch
13.45 Workshop 5 – Audit Reports and Follow-up
Mechanisms for promoting effective corrective and preventive action.
Critical review of an audit report example.
14.30 Workshop 5 - Feedback
14.55 Corrective and Preventive Action and Follow-up
The auditor’s role in monitoring responses to audit and the corrective and preventive actions promised is explored
15.20 Panel Session
An opportunity to get answers to outstanding questions
15.30 Close of course

Back to list

Recommended Products

Booklets

Management of the Training and Competency of Personnel in GxP and Research Environments

Courses

C9083 The Auditing Course (5th Feb 2019 - 6th Feb 2019)

Webcasts

Webcast - Audit Programmes: The Basics
Webcast - Clinical Investigator EU CT Regulation
Webcast - Where Does Audit End?

eLearning Products

Introduction to Managing an Audit Programme elearning
Introduction to the Audit Process elearning

Share