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Audit Programmes and Risk Assessment
If you are wanting to book more than one person onto a course(s) please email courses@therqa.com
For Madingley Hall courses, if you wish to stay for additional nights or double occupancy, please contact the us - courses@therqa.com in the first instance
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
"Both presenters were very knowledgeable and able to enliven discussion with examples from their own experience, which is always incredibly valuable."
CPD Points
7 Points
Course Programme
Please note timings may be subject to alteration
| 8.50 | Registration |
| 9.00 | Welcome and Introduction |
| 9.15 | Why do we Need to Audit? Exploring risk and regulation, responsibility and performance. Understanding the needs of delegates' own organisations and comparing common themes and threats. |
| 10.00 | Establishing an Audit Programme Design, objectives, risk and resources. This session discusses the theory behind managing audit programmes, and how management should lead the auditing process to ensure practice will meet expectations. |
| 10.45 | Break |
| 11.00 | Workshop 1 - Risk and Design Practical issues with regard to objectives and resources are explored. |
| 11.45 | Workshop 1 - Feedback |
| 12.00 | Lunch |
| 13.00 | Putting it into Practice Responsibilities, practicalities and challenges - the realities of auditing. This session explores management's responsibilities and input, including selection of auditors and the reasons to note audit results. |
| 13.45 | Workshop 2- Managing Programmes and Risks Looking at audit programmes and managing risks. Challenges, changes and management responsibilities. |
| 14.45 | Break |
| 15.00 | Workshop 2 - Feedback |
| 15.30 | Monitoring, Reviewing and Improving Why or when should management change existing processes, 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
Following requests from attendees of previous RQA events we are pleased to offer course material 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.
Accommodation
Accommodation is available at Novotel Heathrow and you are responsible for booking this. Details regarding the hotel are available here.
Where the venue is Madingley Hall, accommodation and dinner are available for the dates of the course (we recommend you take this as the location has few nearby facilities).
If you wish to book additional dates please specify in the ‘accommodation requirements’ box when making your booking and we will check availability with Madingley Hall. Bed and Breakfast is £77*, dinner (three courses with drinks, in the main dining room with other course participants) is £35* (* per night per person) - these can be selected during the booking process. As part of the booking process we ask for dietary requirements and these will be taken in to consideration by Madingley Hall. Alternatively bar snacks are available on a pay as you go basis, not bookable through RQA.
Recommended Products
Booklets
Auditing Computerised Systems
Quality Risk Management
Courses
P02 Good Clinical Practice Auditing - Principles and Practice
P08 The Auditing Course
RP02 Good Clinical Practice Auditing - Principles and Practice REMOTE LEARNING
RP09 The Remote Auditing Course REMOTE LEARNING
RP21 Audit Programmes and Risk Assessment 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
