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.
Director, Handy Consulting Ltd (Course Principal)
Associate Director, AstraZeneca
"Both presenters were very knowledgeable and able to enliven discussion with examples from their own experience, which is always incredibly valuable."
Please note timings may be subject to alteration
|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.
|11.00||Workshop 1 - Risk and Design
Practical issues with regard to objectives and resources are explored.
|11.45||Workshop 1 - Feedback|
|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.
|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.
This final session will address any outstanding issues raised by delegates.
|16.30||Close of course|
Following requests from attendees of previous RQA events we are pleased to offer course material in PDF format for delegates attending this 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 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.
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