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Introduction to Computer Systems Validation REMOTE LEARNING

 

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REMOTE LEARNING - this course will be delivered to you live online from the UK. 

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

Keith Thornley
Manager - Information Systems Quality, Eli Lilly & Company Ltd

Recent Feedback

"Excellent courses, knowledgeable tutors with plenty of years of experience in the industry."
"The workshops were very good. It was a good way of taking the information given into "practice" to understand better how to think in different situations."
"Really helped to understand it isn't formulaic and the ability to validate and assess validation is a skill and really depends on the system and the context."

CPD Points

19 Points

Course Programme 

Please note this course will run in UK timezone.

 

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

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.

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
  • Access to an online course group to enhance networking

You will need a stable internet connection, a microphone and a webcam. 

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