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About us
The Auditing Course
Course Information
Designed to develop personal proficiency in audit planning, execution and reporting, this course is meticulously crafted to refine essential audit skill sets. Through immersive scenarios focused on on-site audit conduct (with an alternative Remote Auditing Course available), participants will engage deeply in the audit process.
Extending Expertise:
Applicable across all audit types, this course builds upon and enriches the foundational concepts taught in RQA's suite of research quality assurance courses. From 'Research Quality Assurance for Good Laboratory Practice' to 'Good Clinical Practice Auditing – Principles and Practice' and 'Good Manufacturing Practice for Investigational Medicinal Products,' this programme extends the scope of learning.
Relevance and Value:
Relevant to any area of regulated research and development, this course shines particularly in contexts mandating a quality system for audit. Participants with prior audit experience will gain maximum value from this course.
Key Benefits:
Enrich your skill set to:
- Navigate audit processes encompassing planning, execution, reporting, and follow-up
- Embrace a personalised approach fostering positive audit outcomes
- Analyse evidence and present cohesive audit findings
- Recognise the pivotal role of audits in driving continual improvement.
Interactive Learning:
Structured to foster dynamic engagement, this course encourages delegates to:
- Engage in discussions, idea development, and problem-solving
- Exchange invaluable information and experiences.
Hands-On Experience:
A highlight of this course is the series of practical workshops, where delegates work in small syndicate groups, applying the acquired skills from lectures into real-world scenarios.
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
08:45
Registration
09:00
Welcome and Course Objectives
09:10
What is 'Audit'?
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.
09:30
Audits and their Purpose
The concepts of quality assurance, quality control, quality management and audit are discussed.
10:30
Break
10:45
Audit Planning
The requirements for an effective audit programme and individual audit plans.
11:30
Workshop 1 - Getting the Audit Started
Planning for the audit.
12:25
Workshop 1 - Feedback
12:45
Lunch
13:30
Workshop 2 - Getting the Audit Started
Arranging the opening meeting.
13:50
Workshop 2 - Feedback
Audit initiation. Review and discussion of the role of the opening meeting.
14:25
Auditing Techniques (1) - Data and Documentation
Techniques for the conduct of data and report audits are investigated.
14:55
Break
15:10
Workshop 3 - Data and Documentation Audit
Conducting an audit of a data package and supporting documentation.
17:15
Close of Day
Day 2
09:00
Auditing Techniques (2) - The People
Questioning techniques which get the required information from the auditee.
09:45
Live Audit Role Play
Auditor and auditee behaviours are explored and strategies developed for successful audit interactions.
10:15
Break
10:35
Audit Closing Meeting
An exploration of audit closing meetings.
11:00
Workshop 4 - Audit Observations and Preparing for the Closing Meeting
Reviewing and categorising your observations and getting ready to present your case.
11:45
Workshop 4 - Feedback
12:30
Audit Reports
The content and distribution of an effective audit report are investigated and the importance of effective written communication is discussed.
13:00
Lunch
13:45
Workshop 5 - Audit Reports and Follow-up
Mechanisms for promoting effective corrective and preventive action. Critical review of an audit report example.
14:30
Workshop 5 - Feedback
14:55
Corrective and Preventive Action and Follow-up
The auditor's role in monitoring responses to audit and the corrective and preventive actions promised is explored.
15:20
Panel Session
An opportunity to get answers to outstanding questions.
15:30
Close of Course
Extra Information
Course material
Course material will be available in PDF format for delegates attending this course. 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.
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.
CPD Points
14 Points
Development Level
Develop
Recommended Products
Introduction to Managing an Audit Programme elearning
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Management of the Training and Competency of Personnel in GxP and Research Environments eBooklet
Webcast - Clinical Investigator EU CT Regulation
Webcast - Where Does Audit End?