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.
Tutors will be comprised from the list below:
Director, Cogent QA Ltd (Course Principal)
GCP Auditor and Clinical Research Consultant, Hallam Pharma Consulting Ltd (Course Principal)
Head of Research Quality Assurance, Mundipharma International Technical Operations
Please note timings may be subject to alteration
|8.50||Welcome and Course 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 Finding - 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/non-conformity, 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||Audit Follow Up and 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|
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
P08 The Auditing Course
P11 A Systems Approach to Good Pharmacovigilance Practice
P21 Audit Programmes and Risk Assessment
P34 Practical Approach to Auditing Systems and Processes
P35 Practical Pharmacovigilance Auditing
P36 Practical Approach to Good Pharmacovigilance Regulatory Inspections
P41 Advanced Auditing Skills: Audit Planning and Performance