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About us
Audit Programmes and Risk Assessment REMOTE LEARNING
REMOTE LEARNING - this course will be delivered to you live online from the UK.
If you are wanting to book more than one person onto a course(s) please email courses@therqa.com
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
Recent Feedback
"Incredible training course."
"A really good course with a wealth of experience from the tutors. I think this is the only course on the market around specifically setting up Audit programmes - suitable not just for the GxP industry but those in ISO standards or any Quality management arena. Good opportunities for networking and general discussion amongst attendees also."
"I found Louise to be really insightful and easy to understand. It was a relaxed informal atmosphere and I enjoyed the two workshops."
CPD Points
7 Points
Course Programme
Please note this course will run in UK timezone.
| 8.50 | Registration |
| 9.00 | Welcome and Introduction |
| 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.
Recommended Products
Booklets
Auditing Computerised Systems
Quality Risk Management
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
RP22 Risk Management in Clinical Trials 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
