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
Director and Principal Consultant, Nuncius Compliance Solutions Ltd
BARRY MCMANUS
Consultancy Partner, Empowerment Quality Engineering Ltd
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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
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EXTRA INFORMATION
Face-to-face course
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.
Remote 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.
CPD POINTS
19 Points
DEVELOPMENT LEVEL
Develop