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.
GCP Auditor and Clinical Research Consultant, Hallam Pharma Consulting Ltd (Course Principal)
Associate Director GLP & Research QA
"The discussion between the tutors and the group was excellent, every question got an answer, every action got a feedback"
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.
8.50 Welcome and Course Objectives
9.00 Attendees' Objectives
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
10.45 Workshop 1 – Group Work
11.45 Workshop 1 – Feedback
12.30 Validating Audit Findings - REALISE
Ensuring that your audit findings include all the key attributes necessary to make them intelligible and effective
13.45 Workshop 2 - Validating Audit Findings – REALISE
14.30 What is Important? - Grading Non-conformities
Assessing the importance of your audit findings
Conformity/nonconformity, pass/fail and a variety of grading systems are explored
Includes a discussion of the pros and cons of auditor recommendations
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
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
13.45 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
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’ objectives to ensure they have been met
16.30 Close of course
C9022 GCP Auditing - Principles and Practice
(8th Oct 2018 - 10th Oct 2018)
C9023 GCP Auditing - Principles and Practice (4th Mar 2019 - 6th Mar 2019)
C9041 Research Quality Assurance for GLP (29th Oct 2018 - 30th Oct 2018)
C9082 The Auditing Course (11th Sep 2018 - 12th Sep 2018)
C9083 The Auditing Course (5th Feb 2019 - 6th Feb 2019)
C9112 Systems Approach to Good Pharmacovigilance Practice (16th Oct 2018 - 18th Oct 2018)
C9212 Audit Programmes and Risk Assessment (9th Apr 2019)
C9342 Practical Approach to Auditing Systems and Processes (29th Oct 2018 - 30th Oct 2018)
C9353 Practical Pharmacovigilance Auditing (12th Mar 2019 - 14th Mar 2019)
C9411 Advanced Auditing Skills: Audit Planning and Performance (3rd Sep 2018 - 4th Sep 2018)