SAP - Validation and GMP Compliance - Live Online Training

7/8 November 2023

Course No 19568

This course is part of the GMP Certification Programme "ECA Certified Computer Validation Manager". Learn more.

Note: All times mentioned are CET.

Our Service

Costs

*ECA-Member:**	EUR 1690,--
*Non ECA Member:**	EUR 1890,--
*EU/GMP Inspectorates:**	EUR 945,--
*APIC Member Discount:**	EUR 1790,--

(All prices excl. VAT). Important notes on sales tax.

Registration

* also payable by credit card

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Andreas Busse, Carl Zeiss, Germany
Károly Földesi, SAP Deutschland, Germany
Christian Gasper, DHC Dr. Herterich & Consultants, Germany
Stefan Hessel, Reusch Rechtsanwaltsgesellschaft, Germany
Dr Anne Leutzgen, DHC Dr. Herterich & Consultants, Germany
Thomas Pauly, DHC Dr. Herterich & Consultants, Germany
Thomas Peter, Geistlich Pharma, Switzerland
Dr Wolfgang Schumacher, Formerly F. Hoffmann-La Roche, Switzerland
Stefan Staub, DHC, Switzerland
Dr Laura Stopper, DHC Dr. Herterich & Consultants, Germany

Objectives

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

Background

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.

Target Group

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.

Programme

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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