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03-04 October 2023 04-05 June 2024

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The Remote Auditing Course REMOTE LEARNING

Details
Programme
Extra information

REMOTE LEARNING - this course will be delivered to you live online from the UK.

For R4091 running 3rd-4th October 2023, we have a 20% discount - please enter R409120 in the discount code box at checkout.

If you are wanting to book more than one person onto a course(s) please email courses@therqa.com

Course Information

A two day course specifically designed to provide participants with an understanding of the methods that can be applied to the conduct of remote audits. Analyse the difference between remote and face-to-face audits and the strengths and limitations of each approach. It uses scenarios for the conduct of remote audits (there is an alternative courses for conduct of on-site audits - The Auditing Course)

The course is applicable to any area of regulated research and development. It is particularly valuable where there is a quality system requirement for audit. In order to gain maximum benefit from the course it is recommended that participants have personal experience of audit.

The course applies to all types of audit and develops the concepts and learning delivered in the RQA’s research quality assurance courses; ‘Research Quality Assurance for Good Laboratory Practice’, ‘Good Clinical Practice Auditing – Principles and Practice’ and ‘Good Manufacturing Practice for Investigational Medicinal Products’.

Benefits include improved

Understand the processes of planning, conducting, reporting and follow-up of audits
Recognising the importance of personal approach in developing positive audit outcomes
Ability to analyse evidence and present logical audit findings
Appreciate the importance of audit in continuing improvement

This course is structured to encourage delegates to

Discuss and develop ideas
Solve problems
Exchange information

Course Tutors

Tutors will be comprised from the list below:

Andrew Waddell
Managing Director, Tower Mains (Course Principal)

Cate Ovington
Director, The Knowlogy

Jean McWilliam
Associate Director, Alexion

Recent Feedback

"RQA did a fantastic job bringing this Remote Auditing Course! Everything from the presentations and workshop activities, to the Q&A sessions and accessing documents via Moodle, it all felt very seamless! I would definitely recommend it to anyone looking to grow as an auditor."
"Tutors very experienced and knowledge with the ability to look beyond the obvious, tremendous people skills and very engaging"
"Very experienced and knowledgeable tutor with bags of common sense approach"

Course Programme

Please note this course will run in UK timezone.

Please note timings may be subject to alteration

	Day 1
09:00	Course Administration
09:15	Welcome and Introductions
09:35	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.
10:05	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.
10:30	Break
10:45	Workshop 1 - Remote Audits This workshop will examine participants experience or understanding of the differences between face-to-face and remote audits.
11:15	Workshop 1 - feedback
11:35	Audit Preparation The essential steps in preparation for audits will be discussed with emphasis on remote audits.
12:05	Workshop 2 - Remote Audit Preparation Factors relating to the preparation for remote audits will be considered in discussion groups.
12:35	Workshop 2 - feedback
12:50	Lunch
13:30	Audit Logistics Preparation for the audit includes many arrangements other than the audit content.
14:00	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.
14:30	Workshop 3 - feedback
14:45	Break
15:00	The Opening Meeting Presentation regarding the importance and content of the opening meeting.
15:20	Workshop 4 - Opening Meeting Delegates will consider the practicalities of arranging and conducting an opening meeting.
15:45	Workshop 4 - feedback
16:10	Audit Conduct Tools Practical advice on preparation of some of the tools that will be valuable in the conduct of audits.
16:40	Questions and Answers An overview of the first day and a chance to ask questions
17:00	Close of day
	Day 2
09:00	Reflections on Day 1 Recap on the topics covered and a chance for delegates to raise points.
09:15	Gathering Evidence Presentation on challenges of gathering evidence and conducting interviews during remote audits.
09:45	Workshop 5 - Remote Interviews Scenarios of different remote interviews will be played and delegates assess the strengths and weaknesses of each approach.
10:15	Break
10:30	Creating Audit Findings Ideas regarding how to create good audit findings will be discussed during this short presentation.
10:50	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.
11:35	The Closing Meeting The content and conduct of the closing meeting will be discussed.
11:55	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)
12:15	Workshop 7(b) - The Closing Meeting The Lead Auditor from each group will hold a meeting to present the results (role play).
12:45	Lunch
13:30	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.
14:00	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.
15:00	Workshop 8 - feedback
15:20	Break
15:35	Audit Closure Presentation on how to conclude the audit with reference to post-audit activities.
15:55	Open Forum
16:30	Close of course

Course Material

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.

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
Access to an online course group to enhance networking

You will need a stable internet connection, a microphone and a webcam.

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