The Remote Auditing Course

Description

Join us for a two-day immersive course crafted to equip participants with an in-depth understanding of remote audit methodologies. Delve into the nuances between remote and face-to-face audits, dissecting their respective strengths and limitations. Through practical scenarios tailored for remote audit conduct, this course stands as an essential counterpart to our on-site audits course The Auditing Course.

Applicable across various domains of regulated research and development, this course proves invaluable in contexts requiring a quality system for audit. Participants with firsthand audit experience stand to gain the most benefit from this programme.

This course extends its relevance to all forms of audits and further amplifies concepts explored in RQA's suite of research quality assurance courses, including: 'Research Quality Assurance for Good Laboratory Practice,' 'Good Clinical Practice Auditing – Principles and Practice,' and 'Good Manufacturing Practice for Investigational Medicinal Products.'

Tutors will be comprised of (click the photos for biographies):

Founder Director, Tower Mains Ltd

Senior QA Associate, Tower Mains Ltd

Director, The Knowlogy Group Ltd

Associate Director, Alexion

Please note timings may be subject to alteration.

Course Registration

Welcome and Introductions

Introduction to Audits

Delegates explore the range of audits which they have experienced, define the purpose of each audit type and establish which of those audits are performed to meet regulatory requirements.

Introduction to Remote Audits

Presentation to introduce the major differences between face-to-face audits and remote audits. The major elements of audits will be examined to determine where there may be differences.

Break

Workshop 1 - Remote Audits

This workshop will examine participants experience or understanding of the differences between face-to-face and remote audits.

Workshop 1 - Feedback

Audit Preparation

The essential steps in preparation for audits will be discussed with emphasis on remote audits.

Workshop 2 - Remote Audit Preparation

Factors relating to the preparation for remote audits will be considered in discussion groups.

Workshop 2 - Feedback

Lunch

Audit Logistics

Preparation for the audit includes many arrangements other than the audit content.

Workshop 3 - Audit Logistics

Delegates will discuss some of the issues that may occur during the set up and conduct of remote audits and how to resolve them.

Workshop 3 - Feedback

Break

The Opening Meeting

Presentation regarding the importance and content of the opening meeting.

Workshop 4 - Opening Meeting

Delegates will consider the practicalities of arranging and conducting an opening meeting.

Workshop 4 - Feedback

Audit Conduct Tools

Practical advice on preparation of some of the tools that will be valuable in the conduct of audits.

Questions and Answers

An overview of the first day and a chance to ask questions

Close of Day

Reflections on Day 1

Recap on the topics covered and a chance for delegates to raise points.

Gathering Evidence

Presentation on challenges of gathering evidence and conducting interviews during remote audits.

Workshop 5 - Remote Interviews

Scenarios of different remote interviews will be played and delegates assess the strengths and weaknesses of each approach.

Break

Creating Audit Findings

Ideas regarding how to create good audit findings will be discussed during this short presentation.

Workshop 6 - Creating Audit Findings

Delegates will be provided with examples of evidence from an audit. They will discuss these and create their audit findings for presentation at the closing meeting.

The Closing Meeting

The content and conduct of the closing meeting will be discussed.

Workshop 7(a) - Preparing for the Closing Meeting

The findings from workshop 6 will be reviewed and a Lead Auditor selected to provide feedback in workshop 7(b)

Workshop 7(b) - The Closing Meeting

The Lead Auditor from each group will hold a meeting to present the results (role play).

Lunch

The Audit Report

This presentation will cover not only the essential contents of the audit report but also how to write the report in a manner that will generate the most positive reaction.

Workshop 8 - The Audit Report

Delegates will be provided with an audit report from an audit conducted remotely and will conduct a peer review of the report in their breakout groups.

Workshop 8 - Feedback

Break

Audit Closure

Presentation on how to conclude the audit with reference to post-audit activities.

Open Forum

Close of Course

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.