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About us
Introduction to Computer Systems Validation
Course Information
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.
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.
Is this course for you?
- 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.
Tutors
Tutors will be comprised of (click the photos for biographies):
Nichola Stevens
Nichola is the owner of and Principal Consultant at Nuncius Compliance Solutions Ltd. In this role Nichola helps companies improve overall IT Quality and achieve effective regulatory compliance by performing gap assessments, data integrity evaluations, supplier audits, etc., and proposing and overseeing prioritized remediation activities.
Previously Nichola was the Global Director of Computer System Validation at Alere (now part of Abbott). In this role Nichola was responsible for ensuring that Alere had, and applied, the necessary standards, processes and procedures to deliver high quality, validated computerized systems and to maintain those systems in a compliant manner. This included identifying and managing risks (e.g. cloud computing, outsourcing, data integrity, data center migrations, etc.) that might impact the GxP compliance of Alere’s computerised systems.
Nichola started her career in R&D as a chromatographer with SmithKline Beckman before moving to Oxford Asymmetry International, gaining a first experience of validation. Further experience was gained at Covance before Nichola joined Mi Services as a validation consultant. . Prior to joining Alere, Nichola worked for AstraZeneca as the Global GxP Subject Matter Expert within IT.
Nichola is the Chair of the GAMP UK Steering Committee, a member of the GMP Europe Steering Committee, and a member of the RQA IT Committee.
Barry McManus
Barry is a Principal Consultant for Empowerment Quality Engineering ltd, a Computerised System Validation consultancy that bridges the gap between IT and Quality.
Barry focuses on building quality and security into Computerised Systems (CS) by using quality techniques from the wider software industry while ensuring regulatory compliance. He leads GxP Computerised System (CS) Validation compliance and IT Supplier/Service Provider audits across the globe; performs IT supplier’s software lifecycle process improvement; risk assessments to drive Validation strategies and tailored training.
Barry has over 23 years’ experience in Software Engineering and IT Administration with vast technical knowledge of every role and every activity within the Computerised System lifecycle; development methodologies (traditional and agile), databases and programming languages across multiple technologies. He moved into the regulated industry in 2003 to commence management roles in QA, QC and CS validation. His approach resulted in delivering risk based, on time, right first-time CS validation projects. His experiences ensure that technical and regulatory risks do not compromise CS validation projects, delivers “value add” CS validation documentation and GxP compliance.
He is a member of the RQA’s I.T. committee, the DIA IQCT community core team and a member of the ISPE Data Integrity Project team.
Programme
Please note timings may be 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 Lifecycle
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 three 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
Data Integrity and Security
How can we assure the integrity and security of our data.
15:15
Break
15:30
Course Objectives Summary and Panel Discussion
A round up of key learning from the course.
17:00
Close of Course
Extra Information
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.
Course Material
Course material will be available 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.
CPD Points
19 Points
Development Level
Learn
Recommended Products
Auditing Computerised Systems eBooklet
Computerised System Validation eBooklet
Introduction to the Audit Process elearning
Management of the Training and Competency of Personnel in GxP and Research Environments eBooklet
Webcast - Where Does Audit End?