This course is specifically designed to develop and refine personal skills in the planning, performance and reporting of audits.
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’.
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.
A major feature of the course is a series of practical workshops. Working in small syndicate groups, delegates will be able to put into practice the skills learned during the lectures.
Managing Director, TMQA
Director, Wider Perspectives Ltd
"...they were all equally brilliant tutors. they all bought their own interpretation of fun to the course to help you relax and ... they showed real enthusiasm for what they do which makes it all the more interesting to listen to their experiences and knowledge because they have the passion."
Following requests from attendees of previous RQA events we are pleased to offer course material in PDF format for delegates attending this 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.
Accommodation is available at Madingley Hall for the dates of the course. If you wish to book alternative dates please specify in the ‘accommodation requirements’ box when making your booking and we will check availability with Madingley Hall.
9.00 Welcome and Course Objectives
9.10 What is ‘Audit’?
Delegates explore the range of audits which they have experienced and define the purpose of each audit type
9.30 Audits and Their Purpose
The concepts of quality assurance, quality control, quality management and audit are discussed
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
13.30 Workshop 2 – Getting the Audit Started
Arranging the opening meeting
13.50 Workshop 2 – Feedback
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
15.10 Workshop 3 – Data and Documentation Audit
Conducting an audit of a data package and supporting documentation
17.30 Close of day
9.00 Auditing Techniques (2) – The People
Getting pertinent information from the auditee
9.45 Live Audit Role Play
Auditor and auditee behaviours are explored and strategies developed for successful audit interactions
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
13.45 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
C8012 Auditing Computerised Systems
(16th Apr 2018
- 18th Apr 2018
C8022 GCP Auditing - Principles and Practice (11th Sep 2017 - 13th Sep 2017 )
C8023 GCP Auditing - Principles and Practice (26th Feb 2018 - 28th Feb 2018 )
C8042 Research Quality Assurance for GLP (10th Apr 2018 - 11th Apr 2018 )
C8082 The Auditing Course (30th Oct 2017 - 31st Oct 2017 )
C8141 GCP Regulatory Inspections (30th Oct 2017 - 31st Oct 2017 )
C8211 Audit Programmes and Risk Assessment (31st Oct 2017 )
C8353 Practical Pharmacovigilance Auditing (13th Mar 2018 - 15th Mar 2018 )
C8412 Advanced Auditing Skills: Audit Planning and Performance (19th Feb 2018 - 20th Feb 2018 )
C8421 Advanced Auditing Skills: Audit Analysis and Reporting (6th Sep 2017 - 7th Sep 2017 )
C8422 Advanced Auditing Skills: Audit Analysis and Reporting (21st Feb 2018 - 22nd Feb 2018 )
C9011 Auditing Computerised Systems (4th Feb 2019 - 6th Feb 2019 )
C9083 The Auditing Course (5th Feb 2019 - 6th Feb 2019 )
C9111 Systems Approach to Good Pharmacovigilance Practice (29th May 2018 - 31st May 2018 )
C9112 Systems Approach to Good Pharmacovigilance Practice (16th Oct 2018 - 18th Oct 2018 )