This two day course is the ideal external training opportunity for people needing to gain a basic understanding of computerised system validation. The knowledge gained will help attendees to validate systems within their own organisation for use in GxP (GLP, GCP, GMP, GDP and GPvP) environments, and to audit validated computerised systems to assure compliance with the applicable GxP regulations.
The course starts with an introduction to the regulatory requirements and the system lifecycle and then concentrates on the practicalities of validating computerised systems and auditing these systems.
The course provides a mixture of presentations, discussions and practical workshops.
This course will provide delegates with an understanding of the computerised system validation process, including:
Who should attend
Tutors will be comprised from the list below:
Director and Principal Consultant, Nuncius Compliance (Course Principal)
Consultancy Partner, Empowerment Quality Engineering Ltd
This course is running in our paper format. Access to the course material will not be given to delegates in advance of the course.
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 alternative dates please specify in the ‘accommodation requirements’ box when making your booking and we will check availability with Madingley Hall.
Please note timings are subject to alteration
||Welcome, Introduction and Expectation Setting|
|10.00||Why Validate? Regulations and Guidance on Computerised System Validation
The importance of quality and regulatory requirements and expectations for computerised systems.
|11.00||The System Lifecycle and User Requirements
The concept of the system lifecycle and the key outputs from it including definition of user requirements.
|12.00||Exercise 1 - User Requirements|
Risk management and its impact of validation. Identification of the deliverables required.
The concept of the validation process and the key outputs from it based upon risk.
A discussion on the approaches that might be taken for assessing suppliers and the challenges that might be faced.
|16.30||Exercise 2 - Supplier Assessment
Planning a supplier assessment with a focus on the key validation deliverables.
|17.15||Exercise 2 - Feedback and Model Answer|
|17.30||Close of day|
|9.00||Test Overview and Test Planning
An overview of the different test phases that might be undertaken and how to plan testing based upon risk.
|10.00||Test Script Design and Execution
How to create a test script and considerations for execution of the testing and review of test results.
|11.15||Exercise 3 - Test Script Design|
Comparison of qualification with validation.
|13.30||Overview of Data Integrity and Security Issues
Integrity, security, contingency and continuity planning.
|14.15||Maintaining the Validated State
Discussion of processes required to maintain the validated state including backup and restore, access management, incident management/CAPA and disaster recovery.
How to manage changes to a validated computerised system.
|16.30||Exercise 4 - Change Control
Management of changes to infrastructure, software and data.
|17.15||Course Objectives Summary|
|17.30||Close of course|
P04 Quality Assurance for Good Laboratory Practice
P08 The Auditing Course
P34 Practical Approach to Auditing Systems and Processes
P41 Advanced Auditing Skills: Audit Planning and Performance
P42 Advanced Auditing Skills: Audit Analysis and Reporting