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.
Tutors will be comprised from the list below:
Managing Director, TMQA (Course Prinicpal)
Director, Wider Perspectives Ltd
Principal Associate, TMQA
"...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.
Please note timings may be subject to alteration
|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.
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 interaction
|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|
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.
An opportunity to get answers to outstanding questions.
|15.30||Close of day|
P01 Introduction to Computer Systems Validation
P02 Good Clinical Practice Auditing - Principles and Practice
P04 Research Quality Assurance for Good Laboratory Practice
P11 Systems Approach to Good Pharmacovigilance Practice
P21 Audit Programmes and Risk Assessment
P32 Process Mapping and Using Maps in Standard Operating Procedures Writing
P34 Practical Approach to Auditing Systems and Processes
P35 Practical Pharmacovigilance Auditing
P41 Advanced Auditing Skills: Audit Planning and Performance
P42 Advanced Auditing Skills: Audit Analysis and Reporting