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)
Head of Research Quality Assurance, Mundipharma International Technical Operations Ltd
Associate Director GLP & Research QA, Astrazeneca
"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
9.50 How to Get Started
Getting organised, using the audit plan, grouping observations to facilitate analysis
10.15 Workshop 1 – Getting Started - Introduction
10.45 Workshop 1 – Group Work
11.45 Workshop 1 – Feedback
12.15 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?
assessing the importance of your audit findings
conformity/nonconformity, pass/fail and a variety of grading systems are explored
15.15 Workshop 3 – What is Important? - Group Work
16.00 Workshop 3 – Feedback
16.30 Workshop 4 – Preparing to Present Your Case
Preparing to present to the audit closing meeting.
17.30 Close of day
8.45 Review of Day 1
9.00 Producing the Audit Report
The structure and format of an effective audit report
9.45 Workshop 5 - Introduction
10.00 Workshop 5 – Producing the Report – Group Work
10.45 Workshop 5 – Producing the Report - Feedback
11.00 Workshop 6 – A Perfect Executive Summary? – Group Work
12.00 Workshop 6 - Feedback
13.15 What Happens Next? CAPA
How corrective and preventive action process can drive continual improvement. What is the auditor’s involvement?
14.15 CAPA Workshop and Feedback
15.15 Compliance or Improvement?
The essential difference between compliance and improvement activities. Should the auditor make recommendations? The risks and benefits of audit recommendations and whether or where they have a place are explored
An opportunity for open discussion of issues raised by the course
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
C8012 Auditing Computerised Systems
(16th Apr 2018
- 18th Apr 2018
C8022 GCP Auditing - Principles and Practice (11th Sep 2017 - 13th Sep 2017 )
C8023 GCP Auditing - Principles and Practice (26th Feb 2018 - 28th Feb 2018 )
C8041 Research Quality Assurance for GLP (26th Sep 2017 - 27th Sep 2017 )
C8042 Research Quality Assurance for GLP (10th Apr 2018 - 11th Apr 2018 )
C8082 The Auditing Course (30th Oct 2017 - 31st Oct 2017 )
C8083 The Auditing Course (6th Feb 2018 - 7th Feb 2018 )
C8112 Systems Approach to Good Pharmacovigilance Practice (26th Sep 2017 - 28th Sep 2017 )
C8211 Audit Programmes and Risk Assessment (31st Oct 2017 )
C8352 Practical Pharmacovigilance Auditing (28th Nov 2017 - 30th Nov 2017 )
C8353 Practical Pharmacovigilance Auditing (13th Mar 2018 - 15th Mar 2018 )
C8371 Computerised System Validation (19th Mar 2018 - 21st Mar 2018 )
C8411 Advanced Auditing Skills: Audit Planning and Performance (4th Sep 2017 - 5th Sep 2017 )
C8412 Advanced Auditing Skills: Audit Planning and Performance (19th Feb 2018 - 20th Feb 2018 )
C8422 Advanced Auditing Skills: Audit Analysis and Reporting (21st Feb 2018 - 22nd Feb 2018 )