SAP - Validation and GMP Compliance - Live Online Training
18/19 February 2025
Course No. 21605
Speakers
Andreas Busse
Carl Zeiss
Károly Földesi
SAP Deutschland
Christina Kiefer
Reusch Rechtsanwaltsgesellschaft
Thomas Pauly
DHC Dr. Herterich & Consultants
Christian Gasper
DHC Dr. Herterich & Consultants
Robert Geiger
SAP
Dr. Wolfgang Schumacher
formerly F. Hoffmann-La Roche
Stefan Staub
DHC
Nicole Steffensky
DHC Dr. Herterich & Consultants
Note: All times mentioned are CET.
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 DM). 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 regulatory requirements like EU GMP Guide Annex 11, GAMP® 5 2nd Edition, 21 CFR Part 11 and FDA CSA draft.
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 the regulated Environment of the Life Sciences Industry (Pharmaceutical & Medical Devices).
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.
Testimonials
Seminar Programme as PDF