Practical Approach to Auditing Systems and Processes

Course Information

Our extensively proven course delves into the essential stages of process and system auditing. Gain invaluable insights and direction in auditing systems and processes, spanning across global and local organisational levels.

This course will assist delegates with:

• A practical approach for the development and conduct of process and system audits
• An enhanced understanding of key system audit principles, preparation, design and conduct
• Increased expertise, efficiency and confidence.

This course is structured to encourage delegates to:

• Discuss and develop ideas
• Solve specific problems
• Share knowledge and experiences.

By the end of the course delegates will be better able to:

• Design and plan more effectively to achieve their process and systems audit objectives and add value to their organisation
• Improve the effectiveness, focus and credibility of the audit programme
• Understand the key system audit principles, preparation, design and conduct
• Develop system audit tools to ensure more effective audit conduct and outcome
• Create audit strategies utilising risk management principles
• Prepare for inspections.

Tutors

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

Allison Jack

Executive Director, Bristol Myers Squibb

Rocio Castellanos

Director, Pfizer Ltd

Guy Houben

G(C)LP Auditor, Janssen Pharmaceutical Companies of Johnson & Johnson

Programme

Please note timings may be subject to alteration.

Day 1

08:50

Registration

09:00

Welcome and Introductions, Expectations/Challenges/Experiences

A discussion to explore the range of approaches to the conduct of systems audit.

09:30

Introducing Systems Audit

What is a system? Why conduct system audits? Advantages, disadvantages and challenges.

10:20

Break

10:35

Systems Audit Design and Planning

Identifying the customer, setting objectives, development of the audit plan and audit tools, plans for the audit report.

12:00

Designing System Audit Tools

12:45

Lunch

13:30

System Audit Plan - Exercise

14:00

Introduction to Case Studies

The objectives of the case studies are defined and process and outputs described.

14:15

Case Studies - Session 1

A first opportunity for work on case studies. Defining objectives and scope and understanding the requirements of the audit client.

15:00

Break

15:20

Case Studies - Session 1 continued

16:30

Case Studies - Feedback

17:00

Close of Day 1

Day 2

09:00

Simple System Audit Example - Introduction

The objectives of the case studies are defined and process and outputs described.

09:10

Case Studies - Session 2 - A Simple System Audit Example

An example of system audit applied to a simple system.

10:30

Break

10:45

A Simple System Audit Example - Case Study Feedback

11:30

Strategy

Audit programme planning.

12:15

Lunch

13:00

Case Studies - Session 3

Work on delegate's case studies.

14:30

Break

14:45

Case Studies - Session 3 - Feedback

15:15

Closing remarks

15:30

Close of course