This course is specifically designed to develop and refine personal skills in the planning, performance and reporting of audits. It uses scenarios for the conduct of on-site audits (there is an alternative course for remote audits - The Remote Auditing Course).
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, Tower Mains (Course Principal)
Director, The Knowlogy
Associate Director, Alexion
"Very enthusiastic and an engaging tutor. Made the activities fun and encouraged all to actively participate. I thought tutor was excellent."
"Informative and very helpful. Explains topics in a way that is easy to understand."
"Very informative and engaging. Made the learning experience more fun and interactive."
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 course|
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.
Where the venue is Madingley Hall, accommodation and dinner are available for the dates of the course (we recommend you take this as the location has few nearby facilities).
If you wish to book additional dates please specify in the ‘accommodation requirements’ box when making your booking and we will check availability with Madingley Hall. Bed and Breakfast is £77*, dinner (three courses with drinks, in the main dining room with other course participants) is £35* (* per night per person) - these can be selected during the booking process. As part of the booking process we ask for dietary requirements and these will be taken in to consideration by Madingley Hall. Alternatively bar snacks are available on a pay as you go basis, not bookable through RQA.
P01 Introduction to Computer Systems Validation
P02 Good Clinical Practice Auditing - Principles and Practice
P04 Quality Assurance for Good Laboratory Practice
P11 A Systems Approach to Good Pharmacovigilance Practice
P14 Good Clinical Practice Inspection Preparation - Navigating a Rapidly Changing Environment
P21 Audit Programmes and Risk Assessment
P32 Process Mapping and SOP Writing
P34 Practical Approach to Auditing Systems and Processes
P35 Practical Pharmacovigilance Auditing
P36 Practical Approach to Good Pharmacovigilance Regulatory Inspections
RP01 Introduction to Computer Systems Validation REMOTE LEARNING
RP02 Good Clinical Practice Auditing - Principles and Practice REMOTE LEARNING
RP14 Good Clinical Practice Inspection Preparation - Navigating a Rapidly Changing Environment REMOTE LEARNING
RP32 Process Mapping and SOP Writing REMOTE LEARNING
RP34 Practical Approach to Auditing Systems and Processes REMOTE LEARNING
RP35 Practical Pharmacovigilance Auditing REMOTE LEARNING