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More informationThis 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
Executive Director, Pharmacovigilance & Life Cycle Management, Bristol Myers Squibb (Course Principal)
Rocio Castellanos
Medical Quality Assurance
"I found the course very enjoyable and useful – it has given me lots of ideas to implement in my own organisation."
"Tutor was extremely enthusiastic and obviously has a breadth of experience. She was able to relate different scenarios to the work setting was was useful."
"I found contents of course to be very informative and useful. Will certainly be applying techniques to my work setting."
14 Points
Please note this course will run in UK timezone.
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 |
This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event.
Please note this course will run in UK timezone.
You will need a stable internet connection, a microphone and a webcam.
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
P32 Process Mapping and SOP Writing
P34 Practical Approach to Auditing Systems and Processes
RP01 Introduction to Computer Systems Validation REMOTE LEARNING
RP02 Good Clinical Practice Auditing - Principles and Practice REMOTE LEARNING
RP04 Quality Assurance for Good Laboratory 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