This one day course is designed to provide you with comprehensive guidance and practical help for when designing and implementing audit programmes. Using the guidance of ISO 19011 with reference to PV, GCP, GMP and GLP audit programmes, you will 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.
Tutors will be comprised of (click the photos for biographies):
Please note timings may be subject to alteration.
Exploring risk and regulation, responsibility and performance.
Understanding the needs of delegates' own organisation and comparing common themes and threats.
Design, objectives, risk and resources. This session discusses the consideration when designing audit programmes.
Considerations, guidance and methods for assessing and controlling risk.
Looking at specific risks, assessing and evaluating to feed into audit programme management.
Resources, practicalities and challenges - the realities of auditing, including selection of auditors, ensuring practice will meet expectations and the reasons to note audit results.
Designing audit programmes using output from risk assessment process. Challenges and flexibility.
Why or when should existing processes change, 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.
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.
You will need a stable internet connection, a microphone and a webcam.
Course material will be available in PDF format for delegates attending this course. The advantages of this include:
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.
7 Points
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