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Advanced Auditing Skills: Audit Analysis and Reporting

A 20% discount is available off the course fees for Advanced Auditing Skills: Audit Analysis and Reporting when also booking Advanced Auditing Skills: Audit Planning and Performance. 
To take advantage of this discount, please add both courses to your basket and enter AAS at the checkout.

Course Information

You have completed the observation and recording phase of your audit. You have gathered all your evidence. How are you going to communicate your findings and conclusions? Will things change as a result?

This course will explore principles and best practice in the analysis and reporting of audit findings through informative presentations and practical exercises.

By the end of the course delegates will be better able to

  • categorise, evaluate and prioritise their evidence
  • organise their evidence as audit findings
  • write their findings well and appreciate the value of doing so
  • appreciate the risks associated with poorly written findings
  • write more effective audit reports which achieve their audit objectives and add value

In addition, the course will

  • develop auditor confidence and job satisfaction
  • give auditors the tools necessary to improve their efficiency
  • improve the effectiveness, focus and credibility of the audit programme
  • drive improvement and value for money through thoroughly professional audit

Course Tutors

Tutors will be comprised from the list below:

Julian Reeves
Director, Cogent QA Ltd (Course Principal)

Shirley Hallam
GCP Auditor and Clinical Research Consultant, Hallam Pharma Consulting Ltd (Course Principal)

Joy Eldridge
Head of Research Quality Assurance, Mundipharma International Technical Operations

Claire Dockerill
Associate Director GLP & Research QA 

Recent Feedback

"The discussion between the tutors and the group was excellent, every question got an answer, every action got a feedback"

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 Requirements
(not included in course fees)

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.

Course Programme

Please note timings may be subject to alteration

 

Day 1

8.45   Registration
8.50 Welcome and Course Objectives
9.00 Attendees' Objectives
9.45 Introduction
The starting point for audit analysis and reporting: audit objectives, criteria for process/system performance, records of audit evidence and personal opinion.
10.15 Workshop 1 - Getting Started
Introduction to the Case Study.
10.30 Break
10.45 Workshop 1 - Group Work
11.45 Workshop 1 - Feedback
12.30 Validating Audit Finding - REALISE
Ensuring that your audit findings include all the key attributes necessary to make them intelligible and effective.
13.00 Lunch
13.45 Workshop 2 - Validating Audit Findings - REALISE
14.30 What is Important? - Grading Non-conformities
Assessing the importance of your audit findings
Conformity/non-conformity, pass/fail and a variety of grading systems are explored
Includes a discussion of the pros and cons of auditor recommendations.
15.00 Break
15.15 Workshop 3 - What is Important - Group Work
16.00 Workshop 4 - Preparing to Present Your Case
Preparing to present to the audit closing meeting  
Achieving consensus as the first step to a balanced and effective audit outcome
Incorporates feedback from Workshop 3. 
17.30 Close of day
   
 

Day 2

9.00 Review of Day 1
9.10 Producing the Audit Report
The structure and format of an effective audit report.
10.00 Workshop 5 - Getting Your Point Across: Introduction to the Fogg Factor
10.15 Workshop 5 - Group Work 
10.30 Break (working break during workshop) 
11.15 Workshop 5 - Feedback 
11.30 Workshop 6 - A Perfect Executive Summary? - Group Work 
12.30 Workshop 6 - Feedback
13.00 Lunch 
13.45 What Happens Next? CAPA
How corrective and preventive action process can drive continual improvement  
What is the auditor's involvement? 
14.15 Workshop 7 - CAPA Workshop and Feedback 
14.45 Break
15.00 CAPA Systems
What are the essential elements of an effective CAPA system?  An exploration of principles and methods.
Feedback from the CAPA system survey.
16.00 Wrap up Session/Final Review and Discussion
An opportunity for further open discussion of issues raised by the course  
Revisiting delegates objective to ensure they have been met.
16.30 Close of course

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Recommended Products

Booklets

Management of the Training and Competency of Personnel in GxP and Research Environments
Pharmacovigilance Auditing Booklet

Courses

P01 Introduction to Computer Systems Validation
P02 Good Clinical Practice Auditing - Principles and Practice
P04 Research Quality Assurance for Good Laboratory Practice
P08 The Auditing Course
P11 Systems Approach to Good Pharmacovigilance Practice
P21 Audit Programmes and Risk Assessment
P34 Practical Approach to Auditing Systems and Processes
P35 Practical Pharmacovigilance Auditing
P41 Advanced Auditing Skills: Audit Planning and Performance

Webcasts

Webcast - Where Does Audit End?

eLearning Products

Introduction to Risk Based Quality Systems (RBQS) elearning
Introduction to the Audit Process elearning

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