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SAP - Validation and GMP Compliance - Live Online Training

7/8 November 2023

Seminar-Nr. 19568

Referent:innen

Andreas Busse

Andreas Busse

Carl Zeiss

Károly Földesi

Károly Földesi

SAP Deutschland

Stefan Hessel

Stefan Hessel

Reusch Rechtsanwaltsgesellschaft

Thomas Pauly

Thomas Pauly

DHC Dr. Herterich & Consultants

Christian Gasper

Christian Gasper

DHC Dr. Herterich & Consultants

Dr Anne Leutzgen

Dr Anne Leutzgen

DHC Dr. Herterich & Consultants

Thomas Peter

Thomas Peter

Geistlich Pharma

Dr. Wolfgang Schumacher

Dr. Wolfgang Schumacher

ehemals/formerly F. Hoffmann-La Roche

Stefan Staub

Stefan Staub

DHC

Note: All times mentioned are CET.

Zielsetzung

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
  • What problems could arise during validation and how to solve them
  • How to maintain the validated state of SAP with the least efforts

Hintergrund

SAP S/4HANA has been launched in 2015 as the New Intelligent ERP system. The software is available in both Cloud and Onprem edition. SAP S/4HANA is being called the biggest update to its ERP system in over two decades. Together with the shift to In-Memory database SAP HANA a new user interface (SAP Fiori) was introduced. One of the biggest changes is cloud deployment, parts of SAP Enterprise Architecture are now only available as public cloud software (e.g. SAPs Digital Manufacturing Cloud DMC). This has immense implications for deployment in the Life Sciences industry.
 
The mainstream maintenance for the predecessor products will end in 2027, and SAP has a strong presence in the Life Sciences industry with over 3800 customers. Owing to this timeline 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 Life Sciences customers (for On-prem and Cloud deployments) 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, 2nd Edition and 21 CFR Part 11.

Zielgruppe

This ECA Live Online Training is directed at experienced employees from
  • IT & IT Service Providers
  • Quality Assurance / Quality Control
  • Production / Engineering
who have to deal with SAP S/4HANA in a healthcare environment.

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

SAP - Validation and GMP Compliance - Live Online Training

Gesamtes Programm als PDF herunterladen

New Regulations and Guidelines Covering Computer System Compliance in the GMP Area
  • GAMP® 5, 2nd edition
  • EMA New Annex 11 Concept Paper
  • FDA CSA Draft – meaningful or missing the target?
  • Validation Approach for SAP S/4HANA
Validation Approach for SAP S/4HANA
  • Risk-based validation approach for SAP S/4HANA implementation
  • Risk-based validation approach for transformation SAP ECC to SAP S/4HANA
  • How to harmonize validation and implementation
Case Study: SAP S/4HANA-Implementation and Validation in the Medical Device/Pharmaceutical Industry
  • SAP Multi Product Template build and Roll-Out (S/4, Concur, E-Commerce, Success Factors)
  • Impact on system landscape(s) based on regulatory requirements
  • Resulting challenges for the validation
Agile vs. Waterfall Validation - Is Agile Incompatible with SAP Implementations?
  • Challenges of SAP implementations
  • Applying agile to a large-scale implementation
  • Agile approach to Validation
Audit Trail in SAP S/4HANA
  • Compliance for audit trails: definitions and requirements
  • A risk-based approach to audit trails
  • Implementing and testing audit trails
Implementation of SAP S/4HANA and Data Migration
  • A strategic approach to data migration
  • Regulatory requirements and data migration
  • Validating the data migration
SAP Validation and GMP Compliance - Experience from Inspections and Audits
  • SAP cloud systems in pharmaceutical and medical technology companies
  • Main investigator focus during inspections of a SAP system
  • Operation of SAP on cloud hyperscalers (MS Azure/AWS)
  • Validation and control of SAP updates
  • Use of SAP test automation Tools
Overview SAP in Life Sciences
  • SAP Strategy – enable your success
    • Business agility, supply chain resilience and sustainability outcomes
  • How pharmaceutical solution are embedded in an intelligent & sustainable Enterprise
  • SAP Industry Cloud for Life Sciences – highlighted SAP and Partner Solutions
  • Key takeaways
Validation of SAP (Public) Cloud Solutions
  • Challenges in a public cloud deployment model
  • How can customers gain trust in a public cloud solution?
  • Validating a cloud solution and staying validated
Case Study: Introduction and Validation of SAP Digital Manufacturing Cloud (SAP DMC)
in ZEISS’s Highly Regulated Manufacturing Environment
  • Manufacturing process template based validation approach
  • Agile DevOps and roll-out deployment
  • Keep IT validated – operation of cloud based services
Data Protection and Cyber Security in the Cloud - Legal Challenges and Compliance in Practice
  • Requirements of the GDPR and the data protection supervisory authorities
  • Innovative use of health data and the planned European Health Data Space
  • The EU’s new cybersecurity law: cloud services and the NIS-2 Directive
  • Practical tips on cloud compliance from a lawyer’s perspective
How to Streamline and Speed Up the Validation Process
  • What are prerequisites to streamline and speed up the validation process?
  • Steps to streamline the validation process
  • Efficient, fast methods and tools to speed up the process
  • The role of the supplier(s)
Toolbased Support for Validation and Compliant System Operation
  • Requirements for the digitalisation of validation processes
  • Digitisation of content
  • GxP-compliant release of content, change processand test automatisation
  • Tools

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