Yves Samson
Kereon
Referent:innen
Dr Robert Stephenson
Rob Stephenson Consultancy
Frank Behnisch
CSL Behring
Note: All times mentioned are CET.
Zielsetzung
The programme has been substantially revised for 2025, with increased focus on the periodic review and evaluation of computerised systems in operation. What evidential records need to be maintained, and how can these be efficiently leveraged to confidently demonstrate ongoing compliance to auditors and inspectors?
Four additional good reasons why you should attend:
Four additional 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 system components
- You will learn the importance of role clarity and making best use of Subject Matter Experts and the Quality Unit.
- In workshops / case studies / exercises, you will get the chance to put the theory into practice and discuss suitable solution strategies with your colleagues
Hintergrund
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 GAMP Guides (GAMP®5 2nd Edition and ‘A Risk-Based Approach to Operation of GxP Computerized Systems – A Companion Volume to GAMP®5’).
The course reflects the requirements of the EU Annex 11 and the approaches contained in the GAMP Guides (GAMP®5 2nd Edition and ‘A Risk-Based Approach to Operation of GxP Computerized Systems – A Companion Volume to GAMP®5’).
Zielgruppe
This Education Course is directed at anyone who must deal with the validation and operation of computerised systems and the maintenance of the validated state.
Date & Technical Requirements
Date Live Online Training
Wednesday, 26 February 2025, 09.00 h – 17.30 h CET
Thursday, 27 February 2025, 09.00 h – 17.30 h CET
Friday, 28 February 2025, 09.00 h – 13.00 h CET
Wednesday, 26 February 2025, 09.00 h – 17.30 h CET
Thursday, 27 February 2025, 09.00 h – 17.30 h CET
Friday, 28 February 2025, 09.00 h – 13.00 h CET
Technical Requirements
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Programm
Gesamtes Programm als PDF herunterladen
Welcome / Opening session: What the delegates expect?
- Overview of the Operation Phase
- Capturing delegates expectations
- Sharing and reducing to key points in groups
- Sharing with all delegates and tutors
Periodic Evaluation: Establishing a scalable PE strategy
- Objectives and intention
- Scope of Periodic Evaluation
- Periodic Evaluation: Between efficiency and effectiveness
- What information should be considered?
Handover
- Objectives and purposes
- Roles & Responsibilities
- Handover process
- Acceptance criteria
- Records and reports
Data Integrity in Operation
- ALCOA++ principles
- Technical controls vs procedural controls
- Data governance principles and responsibilities
- Data governance vs IT governance
- Governance pitfalls
Risk Management in Operation
- Risk management according to Q9(R1)
- Risk management applied to change management
- Risk management applied to incident and deviation management
- Keeping risk information up-to-date
Data Management in Operation & Business Continuity
- Understanding the data management processes
- Backup & Restore
- Archiving & Retrieval
- Disaster Recovery & Business Continuity
- Monitoring data management activities
- Records and reports
Change & Configuration Management in Operation
- Objectives
- Configuration management
- Change management
- Types of change
- Organizing effective operational change and configuration management
Incident, Problem & Deviation Management in Operation
- Objectives
- Incident & problem vs deviation
- Incident & problem management process
- Effective Root cause analysis
- Records and reports
CAPA Management in Operation
- CAPA objectives
- Correction vs prevention
- Process collaboration
- Records and reports
Service & Contract Management
- Objective of service and contract management
- Establishing a Service Level Agreement (SLA) and contracts
- SLA key topics
- Monitoring SLAs and contracts
- Records and reports
System Management / System Administration
- Objectives
- Roles & Responsibilities
- Activities to cover
- Records and reports
User Management & Access Control
- Objectives
- User management process
- User management pitfalls
- Records and reports
Security & Performance Monitoring
- Objectives
- Security areas of concern
- Efficient and effective performance monitoring
- Records and reports
Repair & Maintenance
- Objectives
- Points to consider
- Reporting
- Records
Patch & Update Management
- Between security, performance, and compliance
- Risk-based approach to patch and update management
- Patch and update management pitfalls
- Records and reports
Maintaining Cloud / SaaS compliance
- Objectives
- Required controls
- What and how to monitor
- Securing data availability
- Record and Reports
Audit Trail / Audit Trail Review in Operation
- Objectives of audit trail review during operation
- Process relevant vs administrative audit trails
- What to review & how to review
- Records and reports
Performing Periodic Evaluation
- Implementing a scalable approach
- Leveraging existing records
- Learning from the experience
- Securing operational reliability and capability
Retirement Management
- Retirement process objective
- Retirement planning
- Performing retirement
- Consideration to data migration
- Retirement report
Inspection Readiness
- MCO Benchmarking Exercise
- What are the problems with Handover?
- Identifying Risks for Computer Systems in use
- Creating a SLA – What are the key elements?
| ECA-Member*: | € 2090,- |
| Non ECA Member*: | € 2290,- |
| EU/GMP Inspectorates*: | € 1145,- |
| APIC Member Discount*: | € 2190,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
Aufzeichnung nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Computer Validation Manager"
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
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Seminarprogramm als PDF
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