Computerised System Validation: Introduction to Risk Management - Online Training Recording
Course No. 22061
Speakers
Yves Samson
Kereon
Dr Robert Stephenson
Rob Stephenson Consultancy
Objectives
Get to know the current risk management approaches of ICH Q9 and GAMP® 5 2nd Edition
Become familiar with the use of the latest methods and tools for risk analysis when validating computerised systems
Learn how the activities involved in the validation of computerised systems can be controlled efficiently by means of risk management
In 3 workshops you can see how these procedures are applicable
Background
Current GMP regulations and guidelines (EU-GMP Guide Annex 11 ‘Computerised Systems’, ICH Q9, GAMP® 5 2nd Edition, ASTM E2500-20) focus more and more on the topic of risk management. However, the regulations do not offer much concrete advice on how their principles should be translated into practice during the validation and operation of computerised systems. Therefore, it is the aim of this course to provide you with practice-oriented guidance in performing this task.
Target Group
This Online Training is directed at employees from Production, Quality Control / Quality Assurance, Engineering, IT who have to deal with risk assessment and risk management in the field of computerised system validation.
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Technical Requirements
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily Display.
Timing and Duration: When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs. In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate: The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
Programme
Introduction – What Do You Want From This Day?
Capturing delegates expectations
Sharing and reducing to key points in groups
Sharing with all delegates and tutors
An Introduction to Risk Management (including ICH Q9)
Definition of “Quality Risk Management”
Principles of Quality Risk Management
Application of the principles in validation
Methods of assessing and controlling risk
Regulatory expectations for risk management
Risk Management the GAMP® 5 Way
The importance of Risk-based Decision Making
How the GAMP® 5 Risk Management Approach aligns with ICH Q9
The 5-Steps you will need to follow described in detail
Risk Management throughout the System Lifecycle
Short workshop on Risk Identification and Risk Analysis
Risk Assessment the GAMP® 5 Way
The simple GAMP® 5 Risk Assessment Method
Assessment Scales for computerised systems that work
Functional Risk Assessments and Risk Reduction Strategies
Using risk to determine Test Rigour
Case Study / Workshop: Risk Management Applied to a Computerised System
High Level and System Risk Assessment
Evaluating identified risks
Controls to mitigate unacceptable risks
Case Study / Workshop: Functional Risk Assessment Applied to a Control System
How to document a FRA
Classification of risks into H, M, L
What are the conclusions from the risk assessment?
What options do you have to mitigate (reduce) the higher risks?
Using the output to determine verification Tasks?
An Introduction to Risk Ranking
What is risk ranking?
How is it carried out?
How is it documented?
A few useful applications
Case Study / Workshop: Applying Risk Ranking to Determine System Remediation Priorities
How is severity determined?
How can scales be created?
Ranking the risks
Developing a risk-based action plan
Recording from 26 November 2024 Duration of Recording: 4h 11min
This course is part of the GMP Certification Programme "ECA Certified Computer Validation Manager" Learn more
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