Booking options
£851 - £1,105
£851 - £1,105
Delivered In-Person
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 will be comprised of (click the photos for biographies):
Executive Director, Bristol Myers Squibb
Director, Pfizer Ltd
G(C)LP Auditor, Janssen Pharmaceutical Companies of Johnson & Johnson
Please note timings may be subject to alteration.
Registration
Welcome and Introductions, Expectations/Challenges/Experiences
A discussion to explore the range of approaches to the conduct of systems audit.
Introducing Systems Audit
What is a system? Why conduct system audits? Advantages, disadvantages and challenges.
Break
Systems Audit Design and Planning
Identifying the customer, setting objectives, development of the audit plan and audit tools, plans for the audit report.
Designing System Audit Tools
Lunch
System Audit Plan - Exercise
Introduction to Case Studies
The objectives of the case studies are defined and process and outputs described.
Case Studies - Session 1
A first opportunity for work on case studies. Defining objectives and scope and understanding the requirements of the audit client.
Break
Case Studies - Session 1 continued
Case Studies - Feedback
Close of Day 1
Simple System Audit Example - Introduction
The objectives of the case studies are defined and process and outputs described.
Case Studies - Session 2 - A Simple System Audit Example
An example of system audit applied to a simple system.
Break
A Simple System Audit Example - Case Study Feedback
Strategy
Audit programme planning.
Lunch
Case Studies - Session 3
Work on delegate's case studies.
Break
Case Studies - Session 3 - Feedback
Closing remarks
Close of course
Face-to-face course
Course material will be available 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.
Remote course
This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event.
Please note this course will run in UK timezone.
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 Access to an online course group to enhance networking.
You will need a stable internet connection, a microphone and a webcam.
14 Points
Develop