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The Auditing Course

Please note for dates 4th-5th November only a 10% discount is available for this course when booked with a two-day or full 3rd EUQA Conference delegate package.  To take advantage of this discount, please add ALL items to your basket and enter PRECON in the discount code box.  
This course may also be booked as a stand-alone course.

 

RQA CPD Stamp

Course Information

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.

Benefits include improved

  • Organisation of the audit programme to maximise its contribution to quality
  • Audit planning and conduct
  • Effectiveness in communicating audit outcomes
  • Corrective and preventive action

This course is structured to encourage delegates to

  • Discuss and develop ideas
  • Solve problems
  • Exchange information

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.

Course Tutors

Tutors will be comprised from the list below:

Andrew Waddell
Managing Director, TMQA (Course Prinicpal)

Beverley Mehentee
Director, Wider Perspectives Ltd

Cate Ovington
Principal Associate, TMQA

Recent Feedback

"All tutors were excellent; engaging, funny, and provided good practical examples."
" All of the instructors were excellent and engaging."
"All topics were clearly explained, with demonstrations wherever applicable. The training was well delivered. The workshops were very helpful and interactive."
"Can't fault at all!! All excellent speakers, really engaging and encouraging. Very easy to understand and remain attentive."
"Excellent delivery from the tutors. I would have preferred longer on the Workshop 3 Data and Documentation exercise."

CPD Points

14 Points

Course Material

Following requests from attendees of previous RQA events we are pleased to offer course material 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.

Additional Requirement
(not included in course fees)

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 alternative dates please specify in the ‘accommodation requirements’ box when making your booking and we will check availability with Madingley Hall.

Accommodation for C0082

Please see here for accommodation link - for course date 4th-5th November 2019.

Course Programme

Please note timings may be subject to alteration

 

Day 1

8.45 Registration
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.
10.30 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.
17.30 Close of day
   
 

Day 2

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
10.15 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 day

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Recommended Products

Booklets

Management of the Training and Competency of Personnel in GxP and Research Environments

Courses

P01 Introduction to Computer Systems Validation
P02 Good Clinical Practice Auditing - Principles and Practice
P04 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

Webcasts

Webcast - Clinical Investigator EU CT Regulation
Webcast - Where Does Audit End?

eLearning Products

Introduction to the Audit Process elearning

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