Live Online Training - SAP: Validation and GMP Compliance + IT Infrastructure: Qualification and Operation in a GMP Environment

Live Online Training - SAP: Validation and GMP Compliance + IT Infrastructure: Qualification and Operation in a GMP Environment

Course No 17416


Costs

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Speakers

SAP – Validation and GMP Compliance

Elke Brodbeck, DHC AG
Dr Thilo Jania, OLYMPUS EUROPA
Christian Kunath, Santhera Pharmaceuticals
Dennis Leblang, DHC Dr. Herterich and Consultants
Stefan Temps, DHC AG

IT Infrastructure - Qualification and Operation in a GMP Environment

Frank Behnisch, CSL Behring GmbH, Germany
Dr Bob McDowall, R.D.McDowall Limited, UK
Yves Samson, Kereon AG, Switzerland

Objectives

SAP: Validation and GMP Compliance
You will learn
  • How to validate SAP S/4HANA in a GMP environment
  • Which specific requirements should be taken into consideration in the CSV process
  • How to use SAP Solution Manager 7.2 as a validation platform
  • What problems could arise during validation and how to solve them
  • How to maintain the validated state of SAP with the least efforts
 
IT Infrastructure - Qualification and Operation in a GMP Environment
  • Get an overview of technologies discussed currently in the pharmaceutical environment
  • Learn what requirements are placed on the IT infrastructure and its qualification within the scope of GMP regulations
  • Principles outlined can be applied to Operation Technology (OT) for production systems
  • IT security and cybersecurity has now taken on a central role; here you will learn about the importance of the IT infrastructure in terms of an appropriate IT security concept
  • Case studies show you qualification approaches for key IT infrastructure components
  • Virtualization is a part of the IT infrastructure; learn strategies for qualifying the virtual machine and the virtualization platform

Background

SAP: Validation and GMP Compliance
SAP S/4HANA has been launched in 2015 as the new intelligent ERP system. The software is available as cloud edition and as on-prem edition. SAP S/4HANA is being called the biggest update to its ERP system in over two decades. Together with the move to in-memory database SAP HANA a new user interface (SAP Fiori) was introduced.

The mainstream maintenance for the predecessor products will end in 2025. Due to this time line a lot of SAP customers have already started the transformation journey to SAP S/4HANA or at minimum have initiated a pre-project.

How will all these technical and functional changes in the surrounding of SAP S/4HANA (user interface, in-memory database, different deployment types) impact the validation approach and the validation scope?

This ECA Live Online Training will provide comprehensive knowledge about how to validate SAP S/4HANA for new SAP customers as well as for installed base customers who are planning a system conversion.

Expect two days full of shared best practices for the validation of SAP S/4HANA considering recent regulatory requirements like EU GMP Guide Annex 11, GAMP 5 and 21 CFR Part 11.
 
 
IT Infrastructure - Qualification and Operation in a GMP Environment
In today’s pharmaceutical environment, the IT infrastructure is the backbone for the application of a wide range of software solutions. The requirements for IT security are becoming increasingly important. Only a robust IT infrastructure with suitable network topologies and security concepts can guarantee the appropriate security here.

Pharmaceutical regulations contain few or only indirect requirements for the IT infrastructure. The principles of the EU GMP guidelines state “The application should be validated, the IT infrastructure should be qualified”. Here the phrase “should” corresponds to a “must”! Further information can be found in the revised version of the GAMP® Good Practice Guide “IT Infrastructure Control and Compliance” published in August 2017.

Target Group

SAP: Validation and GMP Compliance
This ECA Live Online Training is directed at experienced employees from
  • IT & IT Service Providers
  • Quality Assurance / Quality Control
  • Production / Engineering
 
IT Infrastructure - Qualification and Operation in a GMP Environment
The Live Online Training is aimed at managers from the pharmaceutical industry, suppliers and service companies who plan, qualify and operate IT infrastructure in a GxP Environment.

Technical Requirements

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At https://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programme

SAP: Validation and GMP Compliance
 
Programme Day 1
 
Validation Approach for SAP S/4HANA On Premise
  • Legal requirements
  • Process oriented and risk based approach
  • Best practices
  • Agile vs. V-Model
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?
Case Study: Validation of SAP Cloud Products (Success Factors)
  • Challenges and chances of the new Cloud paradigm
  • Best Practices in validation
  • Supplier qualification of Cloud Providers
  • Operation of Cloud systems
  • Ensuring Data Integrity with Cloud Products
Process Landscape and IT System Landscape
  • Changes in SAP Product Landscape
  • SAP System Landscapes
  • System Landscapes for Transformation Projects
SAP Configuration Management vs. Validation Approach
  • Implementation Approach
  • Customizing and Development
  • Change and Transport System
  • SAP Release Strategy for SAP S/4HANA
  • Validation Challenges
 
Programme Day 2
 
Using SAP Solution Manager 7.2 as a Validation Platform
  • SolMan as Application Lifecycle Management Tool
  • Solution Documentation & Test Management
  • IT Service Management
  • Change Management
  • How can SAP Solution Manager support the S/4HANA transformation?
Case Study: Managing a 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
Transformation to SAP S/4HANA and Data Migration
  • A strategic approach to data migration
  • Regulatory requirements and data migration
  • Validating the data migration
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
Data Integrity
  • Regulatory Requirements
  • Data Integrity Assessment
  • Data Governance System
SAP Audit Trail in SAP S/4HANA
  • Audit Trail functionality in SAP S/4HANA
  • Review of Audit Trail
  • Audit Trail in CSV documentation
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
Templates
All participants get a set of useful templates for download:
  • Validation plan
  • User requirement specifications
  • Functional specifications
  • Test scripts
  • Risk assessment questions
  • Data Integrity Assessment
  • Data migration
 
IT Infrastructure - Qualification and Operation in a GMP Environment
 
Programme Day 1
 
IT/OT Infrastructure Model
  • Overall IT/OT infrastructure enterprise model
  • GAMP IT infrastructure model
  • Applying GAMP software categories
  • OT specifics
  • Applicable to all options: on premise / data hotel / SaaS IT
Regulatory and Legal Requirements / Agreement for IT/OT infrastructure
  • GxP regulations with focus on Annex 11 and Chapter 7
  • Supplier assessment and agreements for IT suppliers
    • Risk management
    • Quality and technical agreements and service levels
    • Governance and Quality oversight
    • Time synchronisation
  • Brief summary of legal requirements
    • e.g. GDPR, HIPAA, etc.
Effective and Efficient Compliance
  • Supporting life cycle model
  • Specification
  • Design
  • Verification
Security and Cybersecurity for a Robust IT/OT Infrastructure
  • IT infrastructure security requirements
  • Cybersecurity: ransomware and malware
  • Sizing / Availability / Reliability
  • Basic security rules
  • Network topology
  • Network segregation
  • IT infrastructure monitoring
  • Recommendation for data archiving support
  • PEN testing
Planning Virtualisation Projects
  • User / Technical Requirements Specification
  • Definition of the installation and deployment approach
  • Risk management
  • Definition of backup cycles and scenarios
  • Efficient planning
  • Qualification planning
  • Life cycle of virtual environment
  • Differences between virtual, physical, and as-a-Service installation and deployment
Virtualisation Platform: Overview
  • Platform operation
    • SANs and VMs handling
  • RAID technology
Qualification of the Virtualisation Platform
  • Platform design
    • Requirements and constraints
    • Data management
    • Disaster recovery
  • Qualification planning
    • Specifications
    • Verifications
Qualification Documentation
  • QP – Qualification Plan
  • TRS – Technical Requirements Specification
  • CS – Configuration Specifications
  • IQ – Installation Qualification a.k.a. Configuration Testing
 
Programme Day 2
 
Design Review of IT Infrastructure
  • Design Review and Risk Management purpose
  • Performing Design Review
  • What might go wrong?
  • Critical review of the IT infrastructure
  • Design and monitoring of mitigation measures
Case Study: Firewall Qualification
  • Requirements
    • Purpose
    • Operation
  • Risk assessment
  • Configuration specification
    • Definition of the security rules
    • Operating parameters
  • Configuration Testing (IQ)
  • Functional Testing (OQ)
  • Operation
    • Monitoring
    • Change & Configuration Management
    • Incident Management
Disaster Recovery Planning
  • Regulatory requirements for disaster recovery
  • For virtual and physical environment
  • Disaster recovery or business continuity plans?
  • Disaster recovery plan and testing
    • Order of application recovery with associated data
    • RPO – Recovery Point Objective
    • RTO – Recovery Time Objective
Case Study: Central Backup Management System
  • Requirements
  • Verification
  • Risk assessment
  • Configuration specification
    • Server / Agent / Operating parameters
  • Configuration Testing (IQ)
  • Functional Testing (OQ)
  • Supporting SOPs
    • System management
    • Backup / Restore
    • Disaster Recovery
  • Operation
Incident and Problem Management
  • Definition of incident and problem
  • Incident investigation
  • Collating incidents into problems and their resolution
  • Linking with change control
Infrastructure as a Platform for Various Applications
  • Definition of Platform
  • Generic approach
  • Standard changes
  • Infrastructure lifecycle challenges for applications & GxP
  • Specialties in automation – challenge for infrastructure in 24/7 real-time applications
Change and Configuration Management
  • Regulatory requirements
  • Definitions of change control and configuration management
  • Outline of a change management process
Agile Infrastructure: Introduction to Infrastructure as Code (IaC)
  • Definition & scope
  • Toys or tool?
    • 40 years evolution
  • Flexibility & Agility
    • From installation to provisioning
  • The costs of Agility
    • Rigorous planning
    • Adequate tools
    • Training
    • Risks and benefits

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