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About us
The Remote Auditing Course
Course Information
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.
Who Should Attend:
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.
Expanding on Previous Learning:
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.'
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.
Tutors
Tutors will be comprised of (click the photos for biographies):
Andrew Waddell
Andrew is recognised as one of the leading motivational trainers in the industry and he specialises in development of excellence in staff and systems. Currently Andrew is Managing Director of a private company providing training, consultancy and audits to ISO 9000, GLP, GMP, GCP, EN540 and ISO 17025. A regular lecturer in Europe and the USA, he has wide experience of working with government and industry bodies and was an adviser to the OECD during the development of the original OECD Principles of Good Laboratory Practice. He completed a two year term of office as Chairman of the British Association of Research Quality Assurance (now the Research Quality Association) and is a member of the American Society of Quality.
Rosemary Ichaba
Cate Ovington
Cate Ovington has over 20 years of experience in Quality Assurance across GLP, GCP (specialising in laboratories), non-regulatory research and computer system validation. Working in diverse organisations, from small to international CROs and academia, and latterly as a consultant working internationally. Cate has experience in performing internal audits, leading audit teams, and performing external audits remotely and on-site.
Jean McWilliam
Based in Basingstoke, UK, and working with Alexion/AZ rare disease unit that aims to save and change the lives of patients with rare diseases by providing new and improved therapies where there is an unmet need. Previous experience in Quality R&D with Shire, Premier Research, Pfizer, Toxicol, and Quintiles. Over 30 years of practical working experience and knowledge of Good Clinical Practice, Good Laboratory Practice, and Good Pharmacovigilance Practice, including developing auditing strategies based on risk, promoting regulatory compliance, data integrity and subject safety. Implementing quality measures and improvements, in both Sponsor companies and CROs. During my career have played a pivotal part in many regulatory inspections and has experience including the MHRA, FDA, EMA and PMDA. Attained the RQA Masters degree in Quality Management in 2012.
Programme
Please note timings may be subject to alteration.
Day 1
09:00
Course Registration
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
Extra Information
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:
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Ability for delegates to keep material on a mobile device
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Ability to review material at any time pre and post course
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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.
Development Level
Develop
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