Computerised System Validation: Maintaining Control of Operation - Online Training Recording
Course No. 21369
Speakers
Yves Samson
Kereon
Dr Robert Stephenson
Rob Stephenson Consultancy
Frank Behnisch
CSL Behring
Objectives
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 systems components
Yuu 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 discuss suitable solution strategies with your colleagues
Background
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 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.
Target Group
This Online Training 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
Engineering /Automation/IT
Software Suppliers and IT Service Providers
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.
Training Course Documentation and Certificate:
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Programme
Introduction – Understanding Delegate Experience and Background
Workshop: What Delegates want to know?
Capturing delegates expectations
Sharing and reducing to key points in groups
Sharing with all delegates and tutors
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
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
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?
Handover and Establishing Support Services
Why does Handover go wrong?
Roles and Responsibilities
Handover Planning
Handover Review and Reporting
Putting Support Services in Place
Case Study / Workshop: Establishing Responsibilities
What tasks are required?
What roles are involved?
What are their responsibilities?
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
Performance Monitoring
Periodic Review considerations
Taking a risk-based Approach
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
Case Study / Workshop: Establishing a simple Service Level Agreement
What are the customer requirements?
What is the supplier specification?
How is performance to be measured?
User Management and Access Control / Training
The role of the System Administrator
Security
Training for everyone!
Training records
Operational Change Control and Configuration Management
Roles and Responsibilities
Sources of changes
Types of changes
Scaling Change and Configuration Management based on Risk
Periodic Evaluation / Audit Trail Review
What is a periodic evaluation (periodic review)?
Which systems are most important?
How do I decide?
How do you perform a periodic evaluation?
Audit trail review considerations during periodic evaluation
Case Study / Workshop: Prioritisation for Periodic Evaluation
What are the important factors to consider?
How can they be effectively assessed?
How can this information be used to determine Overall priorities?
Data Management Processes / Back-up and Restore / Archiving / Retrieval / Deletion
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
Raw Data Management
Definition in regulations and in recent guidances (e.g. MHRA, WHO, FDA)
Risk assessment raw data
Direct product influence
In-direct product influence
Defining raw data
Defending integrity of raw data
Case Study / Workshop: Raw Data Management
Examples from GMP and GLP will be discussed and presented
Data Integrity in the Operation Phase
What are the EU and FDA regulatory expectations?
What are the consequences of data integrity failures – FDA Warning letters etc.
What are the criteria for achieving consistent data integrity – ALCOA+
What are the implications for systems in operation?
How should Audits Trails be managed and reviewed?
Business Continuity Planning and Disaster Recovery
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
Case Study / Workshop: Business Continuity Planning
In a pharmaceutical manufacturing company what systems typically need 24/7 up-time?
Which of these systems has a regulatory requirement for 24/7 up-time?
What are the key elements of a business continuity plan for IT?
Whose responsibility is it to produce the plan?
How would you test it?
Decommissioning, Retirement and Disposal
Withdrawal from active service
Shutting down the system and transfer of data
Disposal of the system
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.
Recording from 11-13 October 2023 Duration of the recording: 15 h 11 min
This course is part of the GMP Certification Programme "ECA Certified Computer Validation Manager" Learn more
Testimonials