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Audit Programmes and Risk Assessment REMOTE LEARNING

RQA CPD Stamp

REMOTE LEARNING - this course will be delivered to you live online from the UK. 

Course Information

This one day course is designed to provide comprehensive guidance and practical help for those who need to design and implement audit programmes. It uses the guidance of ISO 19011 with reference to PV, GCP, GMP and GLP audit programmes to explore audit programme design, operation, review and improvement.
The course will work through why audits are important and understanding the drivers behind a good audit programme. It will discuss how to identify and assess the risks in your organisation, linking them with organisational goals, using these risks as a basis for the design of a risk based audit programme during facilitated practical workshops. Delegates will have the opportunity to consider and discuss common issues and constraints that may shape their audit programmes.

By the end of the course delegates will have

  • a clear understanding of the role of audit programmes in managing compliance and of the drivers and risks behind audit programmes
  • an understanding of the roles and responsibilities of management and personnel
  • an appreciation of resourcing implications and auditor attributes
  • a good insight into the practicalities and activities required for design of risk based audit programmes
  • a comparison of delegates’ circumstances, challenges, common issues and ways to approach managing audit programmes

Course Tutors

Louise Handy
Director, Handy Consulting Ltd (Course Principal)

Vanessa Grant
Associate Director, AstraZeneca

Recent Feedback

"It was made clear what is the purpose of auditing, and why have a good program, and what is the impact of it"
"Presentation style was very clear, she was very friendly and open when facilitating the exercises, with a good sense of humour . It felt like a well structured course with great tutors."
"gave value input, good examples; also quick in responding to questions, clearly explained"

CPD Points

7 Points

Course Programme 

Please note this course will run in UK timezone.

 8.50 Registration 
 9.00 Welcome and Introductio
 9.15 Why do we Need to Audit?
Exploring risk and regulation, responsibility and performance.
09:45 Discussion - Programmes, Needs, Commonalities
Understanding the needs of delegates' own organisation and comparing common themes and threats.
 10.00 Establishing an Audit Programme
Design, objectives, risk and resources.  This session discusses the consideration when designing audit programmes.
 10.30 Break 
10:45 Risk Management
Considerations, guidance and methods for assessing and controlling risk.
 11.00 Workshop 1 - Risks, Prioritisation and Control
Looking at specific risks, assessing and evaluating to feed into audit programme management
 12.00 Workshop 1 - Feedback 
 12.30 Lunch 
 13.30 Putting it into Practice
Resources, practicalities and challenges - the realities of auditing, including selection of auditors, ensuring practice will meet expectations and the reasons to note audit results. 
 13.45 Workshop 2- Designing Audit Programmes 
Designing audit programmes using output from risk assessment process. Challenges and flexibility.
 15.00  Break
 15.15 Workshop 2 - Feedback 
 15.30 Monitoring, Reviewing and Improving
Why or when should existing processes change, understanding the implications of change or inaction and exploring how to improve the audit programme. 
 16.15 Panel Session
This final session will address any outstanding issues raised by delegates.
 16.30 Close of course 

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. 

 

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Recommended Products

Booklets

Auditing Computerised Systems
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Courses

P02 Good Clinical Practice Auditing - Principles and Practice
P21 Audit Programmes and Risk Assessment
RP02 Good Clinical Practice Auditing - Principles and Practice REMOTE LEARNING
RP09 The Remote Auditing Course REMOTE LEARNING

Webcasts

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

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