Prague, Czech Republic
Seminar Nr. 9064
Tel.: 06221 / 84 44 0 E-Mail: email@example.com
CSL Behring GmbH, Germany
Dr David Selby
Selby Hope International, UK
Dr Robert Stephenson
Rob Stephenson Consultancy, UK
Four good reasons why you should attend:
Delegates will gain understanding of the controls needed to maintain validated systems in compliance throughout their operational lifecycle.
Taking a risk-based approach, you will learn how these controls can be scaled across a wide range of computerised systems, allowing you to focus your resources on the most critical systems and the most critical parts of systems.
You will learn the importance of role clarity and making best use of Subject Matter Experts and the Quality Unit.
In workshops, you will get the chance to put the theory into practice and to discuss suitable solution strategies with your colleagues.
The greatest part of the system life cycle is represented by daily operation. It is now a clear regulatory requirement that GxP computerised systems must be kept in compliance throughout their operational lifetime. Audit experience shows that companies struggle with this task. Once the implementation project is complete and the computerised system is handed over for use how can the validated state be maintained? What exactly is required and how can these requirements be successfully established and maintained?
The course reflects the requirements of the new EU Annex 11 and the approaches contained in the ISPE/GAMP Good Practice Guide ‘A Risk-Based Approach to Operation of GxP Computerized Systems – A Companion Volume to GAMP®5’.
Experts from the GAMP® Committee will give you the answers to these questions and give you the opportunity to deepen your understanding by participating in a set of training workshops based on practical real-life examples.
This Education Course is directed at anyone who has to deal with the validation and operation of computerised systems and the maintenance of the validated state. Typically delegates come from:
Manufacturing and Production
Quality Control /Quality Assurance /IT Compliance
Software Suppliers and IT Service Providers
Introduction – Understanding Delegate Experience and Background
Overview of the Operation Phase
Regulatory Context and links with Annex 11
Business process approach, Operational Activities and Information Flows
Roles and Responsibilities, the RACI Model
Periodic Assessment, checks and triggers
Scalability and Risk Management
Other Support Processes
This section introduces the key principles and concepts which can be applied to all operational activities
How well do you maintain the Validated State?
Delegates score themselves
Results consolidated and fed back
Allows delegates to compare their maintenance against best practice and other practitioners
Open session in which delegates discuss how well they maintain the validated state of their systems against current best practices.
Computer Systems in Use: Where are the Risks?
What are the inspectors concerns?
Where does the inspector believe the risks lie?
What will his experience tell him to ask questions about?
How will he assess the seriousness of any failings?
Once the computer system has been validated and is in use, what are the risks from the inspector’s perspective? This session will examine the application of GxP regulations (mostly GMP) to computer systems in operation and identify the risks from the regulatory perspective.
Handover and Establishing Support Services
Why does Handover go wrong?
Roles and Responsibilities
Handover Review and Reporting
Putting Support Services in Place
Effective transition from the Project Phase to the Operation Phase is crucial in order to ensure that the validated status of the system is maintained. This session discusses the handover process, potential causes of failure and how they can be successfully addressed.
Keeping the System Running Smoothly 1 – Service
Management and Performance Monitoring
What Support services are required?
How will Service Delivery be controlled?
Defining Quality Requirements
Periodic Review considerations
Taking a risk-based approach
A closer look at how internal and external support services are defined, agreed and managed.
Keeping the System Running Smoothly 2 – Incident Management, CAPA and System Administration
Dealing with unexpected events
Capturing and Tracking Preventative Actions and Corrective Actions
Preventing Failures and Driving Continuous Improvement
Taking a risk-based approach
A detailed look at two critical processes that will assist in keeping the system running smoothly. The role of the System Administrator in supporting these processes is discussed.
Security and Training
The role of the System Administrator
Training for everyone!
A review of the importance of security and training when creating, managing and maintaining GxP records and a discussion of good-practice controls.
Operational Change Control and Configuration Management
Roles and Responsibilities
Sources of changes
Types of changes
Scaling Change and Configuration Management based on Risk
A topic which is critical to maintaining control; this session will provide practical guidance on the set-up of a risk-based operational change and configuration management process for computerised systems
Periodic Review and Assessment
What is a periodic review?
Which systems are most important?
How do I decide?
How do you perform a periodic review?
Annex 11 states that ‘Computerised systems should be periodically evaluated to confirm that they remain in a valid State’. This presentation discusses in detail what this periodic evaluation includes and how it may be carried out.
System/Data Migration, Back-up and Restore
Regulatory expectations for record retention
What are the considerations for migration?
It will not be perfect process!
Which techniques are most appropriate?
The importance of back-up and its management
The difficulties encountered
These are key areas of regulatory interest. The issues
surrounding data or system migration will be discussed. Then the process of back-up and restore will be reviewed.
Change Management for IT Infrastructure
Process flow diagram for change management
How can this be modified for simple infrastructure changes?
What is the involvement of QA in each of these processes?
Delegates will informed about specific infrastructure needs and the corresponding defence strategy.
Business Continuity Planning and Disaster Recovery – how are these processes integrated?
How to develop a Business Continuity Plan and Disaster Recovery Plan for critical systems
Taking a risk-based approach to disaster recovery testing
This session will provide an overview of the business continuity processes, procedures and evidential records that need to be established in order to demonstrate that critical systems are protected from disaster and that regulatory expectations are met.
Decommissioning, Retirement and Disposal
Withdrawal from active service
Shutting down the system and transfer of data
Disposal of the system
At the end of the operational life, the system must be withdrawn from service and the records managed. This session will look at the phases of retirement, decommissioning and disposal.
Decommissioning Case Study
A Presentation of a real-life case study demonstrating a risk-based approach taken to decommissioning a group of operational systems whilst ensuring that regulatory records were retained for their specified retention periods.
Record Archiving and Retrieval
When is archiving necessary?
It will not be a perfect process!
How should it be indexed?
What are the security issues?
Periodic electronic regeneration
Archiving is appropriate once data volumes are high or the records need to be consulted infrequently. The process needs to be controlled so that the records can still be located and still need to be accessible - sometimes at quite short notice in case of emergency.
Maintain Control in Operation:
This final session will present regulatory observations for review and discussion to help delegates understand the regulatory approach and the way in which observations are written by regulators for maximum impact.
Including 8 interactive Workshops!