SAP: Validation and GMP Compliance + Virtual IT Systems in a GxP Environment
Im Auftrag der ECA Academy

SAP: Validation and GMP Compliance + Virtual IT Systems in a GxP Environment Im Auftrag der ECA Academy

Berlin, Germany

Seminar Nr. 16785


Kosten

Non ECA Member: EUR 2990,--
ECA-Member: EUR 2790,--
EU/GMP Inspectorates: EUR 1690,--
APIC Member Discount: EUR 2890,--

Alle Preise zzgl. MwSt.

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

Dr Thilo Jania, DP/O
Christian Kunath, Vifor Pharma AG
Florian Rauch, DHC Dr. Herterich and Consultants
Stefan Staub, DHC AG
Stefan Temps, DHC AG

Bob McDowall, R.D.McDowall Limited
Yves Samson, Kereon AG
Jürgen Schmitz, GS

Programm

SAP: Validation and GMP Compliance

SAP S/4HANA – Major changes and impact on validation approach
  • S/4HANA - The new digital core
  • Major changes in system architecture
  • What does this mean for the validation approach?
Process Landscape and IT System Landscape
  • Changes in SAP Product Landscape
  • SAP System Landscapes
  • System Landscapes for Transformation Projects
Validation Approach for SAP S/4HANA on premise
  • Legal requirements
  • Process oriented and riskbased approach
  • Best practices
  • Agile vs. V-Model
Validation of SAP Cloud Products
  • Challenges and chances of the new paradigm
  • Best Practices
  • Supplier qualification of Cloud Providers
  • Operation
  • Ensuring Data Integrity with Cloud Products
SAP S/4HANA at Vifor Pharma
  • The global CSV Framework
  • Implementation and Operation of computerized Systems
  • The risk-based approach
  • Inspection experiences
SAP Configuration Management vs. Validation
  • Approach
  • Implementation Approach
  • Customizing and Development
  • Change and Transport System
  • SAP Release Strategy for SAP S/4HANA
  • Validation Challenges
Insights from the Pharma Validation Group (PVG)
  • PVG: Tasks, Objectives, Members
  • Quo Vadis SAP? The journey from Software Manufacturer to Service Provider
  • SAP Audit - change in focus: Frequency and content on the test bench
LIVE DEMO
Using SAP Solution Manager 7.2 as a Validation platform (incl. live demo)
  • SolMan as Application Lifecycle Management Tool
  • Incident Management
  • Change Management
  • How can SAP Solution Manager support the S/4HANA transformation?
Managing an European SAP program in a validated environment (Olympus Surgical Technologies Europe)
  • Project Set-up at Olympus
  • Risk based approach
  • Experiences / Success factors
  • Further implications for the strategic IT-landscape
Intelligent ERP: Artificial Intelligence / Machine Learning and GxP Compliance
  • How can AI / ML support future processes
  • Impact on system design
  • How to handle AI / ML during system validation
Data Integrity
  • Regulatory Requirements
  • Data Integrity Assessment
  • Data Governance System
LIVE DEMO
SAP Audit Trail in SAP S/4HANA
  • Audit Trail functionality in SAP S/4HANA
  • Review of Audit Trail
  • Audit Trail in CSV documentation
Transformation to SAP S/4HANA and Data Migration
  • A strategic approach to data migration
  • Regulatory requirements and data migration
  • Validating the data migration
 
Virtual IT Systems in a GxP Environment
 
Principles of IT qualification and validation
  • Regulatory requirements
  • Definitions
  • Validation and qualification
What is Virtualisation?
  • Definitions
  • Physical platform foundation requirements
  • Software for virtualisation
  • Virtual platform options
Benefits of Virtualisation
  • On demand infrastructure
  • Speed of implementation
  • Flexibility
Regulations apply to Virtualisation
  • Annex 11 key points for consideration
  • IT infrastructure shall be qualified
  • In-house or hosted system
Qualification of IT Infrastructure
  • General Principles of IT Infrastructure Qualification
  • How to do qualification in a real environment vs.what to do in a virtual environment
  • Qualification Activities
  • Roles and responsibilities
  • Installation and Testing
Planning of virtualisation projects
  • User / Technical Requirements Specification
  • Definition of the installation and deployment approach
  • Definition of backup cycles and scenarios
  • From a virtual server to a virtual farm
  • Efficient planning
  • Qualification planning
Compliance requirements for virtual systems
  • IT Infrastructure Platform
  • Server Platform Qualification
  • Virtual Platform considerations
  • Maintaining the Qualified State during operation
Overview of the virtualisation platform
  • Platform components
  • Platform operation
  • Handling of SANs and VMs
Qualification of the virtualisation platform
  • Requirements gathering
  • Platform design
  • Qualification planning
  • Supporting processes
Making of a virtual data centre
  • Specification of virtual data centre requirements
  • Do I qualify or validate the hypervisor software?
  • Building and qualifying a virtual data centre
Risk management
  • ASTM E 2500-07
  • Good Engineering Practice (GEP)
  • Q 9 – Quality risk management
  • GAMP 5, M 3
  • GEP, Qualification, Validation reconciliation
  • NIST-SP 800-30 Risk Management for IT systems
  • HA-Op
Virtualisation of laboratory equipment / Desktop virtualisation
  • Use cases for virtualisation in a laboratory environment
  • Operating a virtual system
Show and tell: Virtualisation documentation
  • Technical Requirements Specification
  • Configuration Specifications
  • Installation Qualification
Change & Configuration Management
  • Regulatory requirements
  • What is a change?
  • Definitions of change management & configuration management
  • An outline change management process
Disaster recovery planning
  • Regulatory requirements for Disaster Recovery
  • Disaster Recovery or Business Continuity Planning?
  • Mitigating physical faults
  • Triggers for the plan
  • Testing the plan
  • Keeping the plan up to date
From virtualisation to Cloud Computing
  • What is Cloud Computing really?
  • Abstraction of services and IT-infrastructure
  • Virtualisation vs. Cloud Computing
  • Recommendations for a GxP compliant Cloud Computing

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