This is an advanced skills course, which will focus on improving the auditor’s performance during audit preparation and conduct, including tips and new strategies to try. Delegates will be expected to reflect on and share their own previous experiences.
This course has the option of Audit Clinics where delegates may request a 1-1 session with a course tutor for advice on any aspect of the audit process.
Who should attend:
Tutors will be comprised from the list below:
GCP Auditor and Clinical Research Consultant, Hallam Pharma Consulting Ltd (Course Principal)
Head of Research Quality Assurance, Mundipharma International Technical Operations
Director, Wider Perspectives Limited
"I liked that the trainers shared their best practices."
Please note timings may be subject to alteration
|13.00||Welcome and Course Objectives
Delegates' Goals and Experiences.
Introduction and Course Aims:
To maximise the value of audit activities on site by effective preparation
To further develop recording and note taking skills
To improve evidence collection through effective communication.
|14.00||Workshop 1 - Audit Plan - Group Work|
|14.25||Workshop 1 - Feedback|
What is the purpose of an audit plan, and what should it contain?
How to prepare for a successful audit.
|15.45||Workshop 2 - Audit Preparation - Group Work
Exercise - introduction to the case study, audit of a contract laboratory.
|17.15||Wrap Up and Close of Day|
|17.30||Audit Clinic - Optional
Delegates may request a 1-1 session with a course tutor for advice on any aspect of the audit process.
|9.00||Review of Day 1|
|9.10||Workshop 3 - The Opening Meeting
Introduction - setting the tone and expectation.
|10.30||Collecting and Recording Audit Evidence
Presentation: Consideration of various recording methods for different audit scenarios, including interviewing, facilities tour, observing practice, document review.
- Recording styles
- Use of media
- Filtering information
- Use of checklists
Delegates will be invited to share their own methods and tips.
|11.30||Workshop 4 - Checklist Task|
|13.00||Dealing with Difficult Situations
Interactive discussion - time to share our audit horror stories!
Presentation - how to get the best out of your auditees.
|13.30||Good Interview Practice
Presentation - interview techniques.
|14.45||Workshop 5 - Auditee Interview|
Workshop 6 - Process Observation
|16.15||Summary of Course and Wrap Up
An opportunity for further open discussion of issues raised by the course. Revisiting delegates' objectives to ensure they have been met.
|17.00||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
P42 Advanced Auditing Skills: Audit Analysis and Reporting