The Auditing Course

Course Information

Designed to develop personal proficiency in audit planning, execution and reporting, this course is meticulously crafted to refine essential audit skill sets. Through immersive scenarios focused on on-site audit conduct (with an alternative Remote Auditing Course available), participants will engage deeply in the audit process.

Extending Expertise:

Applicable across all audit types, this course builds upon and enriches the foundational concepts taught in RQA's suite of research quality assurance courses. From 'Research Quality Assurance for Good Laboratory Practice' to 'Good Clinical Practice Auditing – Principles and Practice' and 'Good Manufacturing Practice for Investigational Medicinal Products,' this programme extends the scope of learning.

Relevance and Value:

Relevant to any area of regulated research and development, this course shines particularly in contexts mandating a quality system for audit. Participants with prior audit experience will gain maximum value from this course. 

Key Benefits:

Enrich your skill set to:

• Navigate audit processes encompassing planning, execution, reporting, and follow-up
• Embrace a personalised approach fostering positive audit outcomes
• Analyse evidence and present cohesive audit findings
• Recognise the pivotal role of audits in driving continual improvement.

Interactive Learning:

Structured to foster dynamic engagement, this course encourages delegates to:

• Engage in discussions, idea development, and problem-solving
• Exchange invaluable information and experiences.

Hands-On Experience:

A highlight of this course is the series of practical workshops, where delegates work in small syndicate groups, applying the acquired skills from lectures into real-world scenarios.

Tutors

Tutors will be comprised of (click the photos for biographies):

Andrew Waddell

Founder Director, Tower Mains Ltd

Rosemary Ichaba

Senior QA Associate, Tower Mains Ltd

Cate Ovington

Director, The Knowlogy Group Ltd

Jean McWilliam

Associate Director, Alexion

Programme

Please note timings may be subject to alteration.

Day 1

08:45

Registration

09:00

Welcome and Course Objectives

09:10

What is 'Audit'?

Delegates explore the range of audits which they have experienced, define the purpose of each audit type and establish which of those audits are performed to meet regulatory requirements.

09:30

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.

17:15

Close of Day

Day 2

09:00

Auditing Techniques (2) - The People

Questioning techniques which get the required information from the auditee.

09:45

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

Extra Information

CPD Points

14 Points

Development Level

Develop