For Madingley Hall courses, if you wish to stay for additional nights or double occupancy, please contact the us - courses@therqa.com in the first instance
This well established course will explore key phases of process and system auditing. It will provide guidance on auditing systems and processes at both the global and local organisational level.
Tutors will be comprised from the list below:
Allison Jack
PVQA Director, GlaxoSmithKline (Course Principal)
Karen Leysen
Associate Director, Johnson & Johnson
Rocio Castellanos
Medical Quality Assurance
"I found the exercises to be relevant, useful, and educational. Group work is always a good opportunity to gain information on different viewpoints and practices."
"Very experienced speakers."
14 Points
Please note timings may be subject to alteration
Day 1 |
|
8.50 | Registration |
9.00 | Welcome and Introductions, Expectations/Challenges/Experiences A discussion to explore the range of approaches to the conduct of systems audit. |
9.30 | Introducing Systems Audit What is a system? Why conduct system audits? Advantages, disadvantages and challenges. |
10.20 | Break |
10.35 | Systems Audit Design and Planning Identifying the customer, setting objectives, development of the audit plan and audit tools, plans for the audit report. |
12.00 | Designing System Audit Tools |
12.45 | Lunch |
13.30 | System Audit Plan - Exercise |
14.00 | Introduction to Case Studies The objectives of the case studies are defined and process and outputs described. |
14.15 | Case Studies - Session 1 A first opportunity for work on case studies. Defining objectives and scope and understanding the requirements of the audit client. |
15.00 | Break |
15.20 | Case Studies - Session 1 continued |
16.30 | Case Studies - Feedback |
17.00 | Close of day |
Day 2 |
|
9.00 | A Simple System Audit Example - Introduction The objectives of the case studies are defined and process and outputs described. |
9.10 | Case Studies - Session 2 - A Simple System Audit Example An example of system audit applied to a simple system. |
10.30 | Break |
10.45 | A Simple System Audit Example - Case Study Feedback |
11.30 | Strategy Audit programme planning. |
12.15 | Lunch |
13.00 | Case Studies - Session 3 Work on delegate's case studies. |
14.30 | Break |
14.45 | Case Studies - Session 3 - Feedback |
15.15 | Closing remarks |
15.30 | 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
P14 Good Clinical Practice Inspection Preparation - Navigating a Rapidly Changing Environment
P32 Process Mapping and SOP Writing
RP01 Introduction to Computer Systems Validation REMOTE LEARNING
RP02 Good Clinical Practice Auditing - Principles and Practice REMOTE LEARNING
RP09 The Remote Auditing Course REMOTE LEARNING
RP14 Good Clinical Practice Inspection Preparation - Navigating a Rapidly Changing Environment REMOTE LEARNING
RP22 Risk Management in Clinical Trials REMOTE LEARNING
RP32 Process Mapping and SOP Writing REMOTE LEARNING
RP34 Practical Approach to Auditing Systems and Processes REMOTE LEARNING