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About us
Introduction to Computer Systems Validation
If you are wanting to book more than one person onto a course(s) please email courses@therqa.com
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
Course Information
This three 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:
- Definition of end user requirements
- Risk management, including supplier assessment and techniques for audit planning
- Validation planning and reporting
- Linking system development with good business practices
- Formal testing and qualification
- Understanding of data integrity and security issues
- How to assess system validation documentation to verify compliance
Who should attend
- IT professionals new to implementing computerised systems into regulated environments
- Quality professionals who monitor or audit computerised systems
- System owners, end users, tester and project staff
Course Tutors
Tutors will be comprised from the list below:
Nichola Stevens
Director and Principal Consultant, Nuncius Compliance (Course Principal)
Barry McManus
Consultancy Partner, Empowerment Quality Engineering Ltd
Recent Feedback
"Huge amount was provided and in details for an introductory course."
"I liked Barry that used schemes to explain the unimaginable IT part. Very helpful during the exercise and quite open to share ideas and suggestions."
CPD Points
19 Points
Course Programme
Please note timings are subject to alteration
Day 1 |
|
| 09:00 | Welcome, Introduction and Course Objectives |
| 09:45 | Why Validate? Regulations and Guidance on Computerised System Validation Overview of the regulations and guidance applicable to CSV and their key expectations |
| 10:30 | Break |
| 10:45 | The System Lifecyle The concept of the SLC and the key outputs from it |
| 12:00 | Lunch |
| 12:45 | The Validation Process The approach to validation for different system types and a look at some of the key deliverables |
| 14:00 | Project Introduction |
| 14:15 | Exercise 1 - User Requirements Capturing, agreeing and documenting the user requirements for a system |
| 15:15 | Break |
| 15:30 | Exercise 1 - feedback |
| 16:00 | Risk Management Risk management and its impact on validation. Identifying the deliverables required. Then group discussion on risk assessment for 3 systems |
| 17:00 | Questions and Answers Answers to any outstanding questions from Day 1 |
| 17:15 | Close of Day |
Day 2 |
|
| 09:00 | Supplier Assessment The different approaches to supplier assessment and the things to be considered when assessing a supplier |
| 10:15 | Exercise 2 - Supplier Assessment Planning a vendor audit with a focus on the key validation deliverables |
| 11:00 | Break |
| 11:15 | Exercise 2 - feedback |
| 11:45 | Test Overview and Test Planning The different test phases, the purpose of each test phase and things to be considered when planning and reporting testing |
| 12:45 | Lunch |
| 13:30 | Test Overview and Test Planning Continued |
| 14:15 | Test Script Design, Execution and Review What a good test script looks like and the key things to consider when creating, executing and reviewing a test script |
| 15:30 | Break |
| 15:45 | Exercise 3 - Creating a Test Script Create a test script based on user requirements created on Day 1 |
| 17:15 | Close of Day |
Day 3 |
|
| 09:00 | Exercise 3 feedback |
| 09:30 | Infrastructure Configuration and Qualification |
| 10:30 | Break |
| 10:45 | Validation Reporting Overview of the Validation Report and what should be included in it |
| 11:15 | Maintaining the Validated State The procedures and records needed to ensure the system remains fit for purpose |
| 12:30 | Lunch |
| 13:15 | Change Control Key concepts related to making changes to validated systems |
| 14:00 | Exercise 4 - Change Control |
| 14:45 | Exercise 4 - feedback |
| 15:15 | Break |
| 15:30 | Data Integrity and Security How can we assure the integrity and security of our data |
| 16:45 | Course Objective Summary and Panel Discussion |
| 17:00 | Close of course |
Course Material
Following requests from attendees of previous RQA events we are pleased to offer course material in PDF format for delegates attending this course.
The advantages of this include
- Ability for delegates to keep material on a mobile device
- Ability to review material at any time pre and post course
- Environmental benefits – less paper being used per 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.
You will also receive a copy of our booklet - "Auditing Computerised Systems"
Additional Requirements
(not included in course fees)
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.
Recommended Products
Booklets
Auditing Computerised Systems
Computerised System Validation
Management of the Training and Competency of Personnel in GxP and Research Environments
Courses
P04 Quality Assurance for Good Laboratory Practice
P08 The Auditing Course
P34 Practical Approach to Auditing Systems and Processes
RP01 Introduction to Computer Systems Validation REMOTE LEARNING
RP09 The Remote Auditing Course REMOTE LEARNING
RP34 Practical Approach to Auditing Systems and Processes REMOTE LEARNING
RP37 Auditing Computerised Systems REMOTE LEARNING
Webcasts
Webcast - Where Does Audit End?
