Computerised System Validation - Introduction to Risk Management + GAMP 5 Approach
6-9 May 2025, Vienna, Austria
Course No. 21553
Speakers
Yves Samson
Kereon
Dr Robert Stephenson
Rob Stephenson Consultancy
Frank Behnisch
CSL Behring
Objectives
Computerised System Validation: Introduction to Risk Management
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
Computerised System Validation: The GAMP® 5 Approach
Why you should attend this Training:
You will systematically be introduced to the principles and methods of the validation of computerised systems (according to GAMP®)
You will learn the skills to plan, implement and document effectively validation activities for computerised systems and to assess them with respect to their GxP compliance
In workshops / interactive sessions you can see how the theoretical foundations will apply practicable
Background
Computerised System Validation: Introduction to Risk Management
Current GMP regulations and guidelines (EU-GMP Guide Annex 11 ‘Computerised Systems’, ICH Q9, GAMP®5, 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.
Computerised System Validation: The GAMP® 5 Approach
Computerised systems are a central factor determining work sequences in the pharmaceutical industry. Their use increases product safety and saves time and costs of manual intervention. This creates the requirement and necessity, however, to validate all computerised systems which can influence the quality of pharmaceutical products.
The basis of the training will be the current requirements for the validation of computerised systems like GAMP® and their GxPoriented application in practice.
Experts from the pharmaceutical industry and from the GAMP® Committee will show you efficient ways to validate your computerised systems.
Target Group
Computerised System Validation: Introduction to Risk Management
This 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 computer validation.
Computerised System Validation: The GAMP® 5 Approach
This Training is directed towards specialists and executives in the pharmaceutical industry entrusted with the planning, implementation and evaluation of the validation of computerised systems.
Testimonials
Seminar Programme as PDF