Computerised System Validation: Introduction to Risk Management
Learn how to plan, implement and document effectively Computer Validation
27 April 2027, Vienna, Austria
Course No. 22792
Highlights - 3 Workshops
Combination booking: We offer you a discount of 600 EUR if you book this training course together with the course "Computerised System Validation: The GAMP® 5 Approach" from 28-30 April 2027. Book both courses directly as a combination here.
Target Group
This Training Course is directed at specialists and executives from
Production
Quality Control / Quality Assurance
Engineering /Automation
IT
who have to deal with computerised system validation.
Objectives
Get to know the current risk management approaches of ICH Q9 (R1) and GAMP®5 Second 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
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
Workshop: Risk Management Applied to a Computerised System
High Level and System Risk Assessment
Evaluating identified risks
Controls to mitigate unacceptable risks
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
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
Further Information
Venue Austria Trend Parkhotel Schönbrunn Hietzinger Hauptstr. 10-14 1030 Vienna, Austria Phone +43 1 878 08-0 Email parkhotel.schoenbrunn@austria-trend.at
Accommodation CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form/POG when you have registered for the course. Reservation should be made directly with the hotel. Early reservation is recommended.
Conference language The official conference language will be English.
Fees (per delegate, plus VAT) ECA Members 1,090 EUR APIC Members 1,190 EUR Non-ECA Members 1,290 EUR EU GMP Inspectorates 645 EUR The conference fee is payable in advance after receipt of invoice and includes conference documentation, lunch and all refreshments. VAT is reclaimable.
We offer you a discount of 600 EUR if you book this training course together with the course "Computerised System Validation - The GAMP® 5 Approach " on 28-30 April 2027. Book both courses directly as a combination here.
Get Together On Tuesday evening (27 April), you are cordially invited to a get together. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
Presentations/Certificate The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site.
Testimonials
