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About us
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
Rocio Castellanos
Rocio Castellanos obtained her BSc in Chemistry from the University of Oviedo, Spain completing her final University year with a grant in Dublin City University, Republic Of Ireland. She joined the Quality Assurance world in 1996 working for a CRO in Dublin and in 2001 joined the Pharmaceutical industry. Since then Rocio has a vast amount of experience in dealing with regulatory compliance, Pharmacovigilance and GCP issues on a global basis.
Rocio has delivered at a few international QA conferences. A British Association Research Quality Assurance (BARQA) member since 1996, Rocio was awarded the Diploma in Research Quality Assurance in 2001.
Guy Houben
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
Extra Information
Course Material
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.
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 Access to an online course group to enhance networking
You will need a stable internet connection, a microphone and a webcam.
Course Material
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.
CPD Points
14 Points
Development Level
Develop