Introduction to Computer Systems Validation

Description

Join our comprehensive three-day training programme tailored for individuals seeking a foundational grasp of computerised system validation. This course equips participants with essential knowledge to effectively validate systems within their respective organisations for utilisation in GxP (GLP, GCP, GMP, GDP, and GPvP) environments. Attendees will also gain proficiency in auditing validated computerised systems, ensuring compliance with pertinent GxP regulations.

Commencing with an overview of regulatory prerequisites and the system life cycle, the course transitions into practical aspects, centered around validating computerised systems and conducting subsequent audits.

Engage in a dynamic blend of presentations, interactive discussions, and hands-on practical workshops throughout the course.

Tutors will be comprised of (click the photos for biographies):

Director and Principal Consultant, Nuncius Compliance Solutions Ltd

Consultancy Partner, Empowerment Quality Engineering Ltd

Please note timings may be subject to alteration.

Welcome, Introduction and Course Objectives

Why Validate? Regulations and Guidance on Computerised System Validation

Overview of the regulations and guidance applicable to CSV and their key expectations.

Break

The System Lifecycle

The concept of the SLC and the key outputs from it.

Lunch

The Validation Process

The approach to validation for different system types and a look at some of the key deliverables.

Project Introduction

Exercise 1 - User Requirements

Capturing, agreeing and documenting the user requirements for a system.

Break

Exercise 1 - Feedback

Risk Management

Risk management and its impact on validation. Identifying the deliverables required. Then group discussion on risk assessment for three systems.

Questions and Answers

Answers to any outstanding questions from Day 1.

Close of Day

Supplier Assessment

The different approaches to supplier assessment and the things to be considered when assessing a supplier.

Exercise 2 - Supplier Assessment

Planning a vendor audit with a focus on the key validation deliverables.

Break

Exercise 2 - Feedback

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.

Lunch

Test Overview and Test Planning

Continued.

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.

Break

Exercise 3 - Creating a Test Script

Create a test script based on user requirements created on Day 1.

Close of Day

Exercise 3 Feedback

Infrastructure Configuration and Qualification

Break

Validation Reporting

Overview of the Validation Report and what should be included in it.

Maintaining the Validated State

The procedures and records needed to ensure the system remains fit for purpose.

Lunch

Change Control

Key concepts related to making changes to validated systems.

Data Integrity and Security

How can we assure the integrity and security of our data.

Break

Course Objectives Summary and Panel Discussion

A round up of key learning from the course.

Close of Course

Face-to-face course

Course material will be available in PDF format for delegates attending this course. The advantages of this include:

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.

Remote 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.

19 Points

Develop