Yves Samson
Kereon
Referierende
Dr Robert Stephenson
Rob Stephenson Consultancy
Frank Behnisch
Formerly CSL Behring
Highlights
- Relevance of EU GMP Guide Annex 11 and GAMP®5 2nd Edition
- The GAMP® 5 Risk-Based Approach to Operation of GxP Computerized Systems Good Practice Guide
- Change Control and Configuration Management
- Relevance of EU GMP Guide Annex 11 and GAMP®5 2nd Edition
- The GAMP® 5 Risk-Based Approach to Operation of GxP Computerized Systems Good Practice Guide
- Change Control and Configuration Management
Zielgruppe
With experts from:
- IT,
- Quality Assurance,
- Production / Quality Control,
- Technology,
- System Suppliers and Service Providers,
who must deal with the validation and operation of computerized systems, the maintenance of the validated state, and the maintenance and operation of legacy systems in accordance with regulatory requirements.
Zielsetzung
- 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
Programm
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
Workshops / Case Studies / Exercises
- MCO Benchmarking Exercise
- What are the problems with Handover?
- Identifying Risks for Computer Systems in use
- Creating a SLA – What are the key elements?
Weitere Informationen
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 recording, you can decide on what date you want to watch the training course online. Starting from the access date you entered during the registration process, the stream will be available to you for 7 days. Within this timeframe, you can start and 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.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
Timing and Duration:
When you register for the recording, you can decide on what date you want to watch the training course online. Starting from the access date you entered during the registration process, the stream will be available to you for 7 days. Within this timeframe, you can start and 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.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
Contacts
Questions regarding content:
Dr Andreas Mangel, +49 6221 84 44-41, mangel@concept-heidelberg.de
Questions regarding Organisation:
Ms Marion Grimm, +49 6221 84 44-18, marion.grimm@concept-heidelberg.de
Recording from 30 September - 02 October 2026
Duration of Recording: 14h 12m
Duration of Recording: 14h 12m
Teilnahmegebühr
| ECA-Member*: | € 2290,- |
| Regular Fee*: | € 2490,- |
| EU/GMP Inspectorates*: | € 1245,- |
| APIC Member Discount*: | € 2390,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine 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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