Reasons to attend

This 1-day course on how to apply a risk-based approach to clinical audits will allow you to:

• Understand your organisation’s approach to risk
• Develop a QA risk strategy
• Apply a risk-based approach to the development of your audit program
• Adopt a risk-based approach in the execution of individual audits

Consider the challenges of auditing Risk Based Monitoring trials. The course includes cases studies, short exercises and a final evaluation to encourage understanding.

What's included?

• Documents and materials related to this course are included
• Globally recognised certificates awarded after test completion
• This course has been granted PharmaTrain Recognition

Course schedule

We provide this course in two distinct formats: Classroom OR Online

Classroom: 1-Day face-to-face: 09:00 - 17:00

Online: 2 webinar sessions

Course Description

Where you choose to focus your valuable QA resource, will ultimately determine what you discover at audit. The application of a robust risk-based approach to auditing is required to maximise the value of your QA resource, by focusing on the areas that matter and will add the most benefit to your company.

In the new ICH GCP E6 R2 world, a risk-based approach to clinical trials, including audits is essential. Companies manage risk at many different levels. The QA group will need to be able to evaluate their company’s approach to risk, including the way risks are evaluated and visualised to determine if the approach is fit for purpose. The application of risk-based approach to clinical audits can be challenging as it requires:

• An understanding of the companies’ approach to risk
• An ability to identify and assess the potential compliance risks of the company business strategy
• An ability to challenge the risk-based approach in the conduct of clinical trials

Clinical auditors and quality professionals will need to have the skills and confidence to embrace these challenges and understand how to apply a risk-based approach to clinical audits and how this approach can be leveraged in the delivery of high quality audits.

This course provides you with the grounding that will allow you to become familiar with the impact a risk-managed audit program can have on the successful execution of clinical trials and how it can be applied to the key aspects of planning, preparing, developing and conducting clinical audits.