Yves Samson
Kereon
Referent:innen
Stefan Münch
Körber Pharma Consulting
All times mentioned are CEST.
Zielsetzung
- You will gain a basic understanding of IT systems and how they work
- You will learn how software is developed and tested
- Data integrity is one of the basic requirements in the GMP world. What is the relevant data and how can its integrity be ensured?
- You will be able to assess how the diverse and often very short-term technological developments in the IT sector are to be evaluated against the background of pharmaceutical requirements
Hintergrund
In today’s world, company operation is no longer possible without the use of IT. In the healthcare industry, as well, IT systems play an important role in all areas. In many cases, it is sufficient for the user to be able to operate the IT systems without knowing their basic functions.
In a highly regulated industry, the use of IT systems, especially with their ever-increasing networking, is also associated with risks and dangers. Currently, for example, the media extensively report about topics such as data and system security. The pharmaceutical industry has to face these topics in many respects.
Only those who know the characteristics and modes of operation of the systems and can assess their problems and dangers, are in a position to ensure the proper and safe operation of these systems.
In a highly regulated industry, the use of IT systems, especially with their ever-increasing networking, is also associated with risks and dangers. Currently, for example, the media extensively report about topics such as data and system security. The pharmaceutical industry has to face these topics in many respects.
Only those who know the characteristics and modes of operation of the systems and can assess their problems and dangers, are in a position to ensure the proper and safe operation of these systems.
Zielgruppe
The seminar is aimed at employees of pharmaceutical and medical companies, suppliers and service companies who deal with IT systems, but do not have a detailed understanding of their technical functions.
Technical Requirements
Date of the Live Online Training
Thursday, 09 October 2025, 09.00 h – 18.00 h CEST
Friday, 09 October 2025, 09.00 h – 17.30 h CEST
Thursday, 09 October 2025, 09.00 h – 18.00 h CEST
Friday, 09 October 2025, 09.00 h – 17.30 h CEST
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.
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Programm
Gesamtes Programm als PDF herunterladen
CSV regulatory Background
- What is a computerised system?
- Applicable regulatory Framework
- What the heck does qualification and validation actually mean?
- PIC/S
Technology: Hardware & Software Components
- Company IT infrastructure
- Network components
- Switches, hubs and Firewalls
- Server farm vs blade centre
- Storage Systems
- NAS & SAN
IT Landscape
- IT vs OT
- Specificities and features of IT Systems
- Controllers and process control Systems
- MES
- ERP
- LIMS
- CDS
- DMS - Technology
- Bare metal
- Virtualisation
About Data
- Process data
- Initial / raw data
- Data integrity: ALCOA+
- The importance of data
Data Management
- Definitions
- Terminology
- Roles
- Data LifeCycle
- Data governance - Challenges of today‘s data Management
- RAID Technology
- Disaster Recovery & Business Continuity
- Data Migration
Basics of Software Engineering
- Reference model
- V-model according to GAMP®
- ASTM E2500-20
- Spoon model
- Operation
Alternative System Development Approaches
- Alternative software development models
- Agility objectives
- Example: Scrum4LS as an agile SW development model
- Icing on the cake: Continuous integration and test Automation
- DevOps: How far can we go?
Computerised System Validation - 1 -
- Basic principles
- URS – User Requirements Specification
- Responsibilities
- GAMP® software categories
- Risk Management
Computerised System Validation - 2 -
- Use cases / User stories
- Creating URS interactively
- Testing
- Automated testing
- Traceability
GAMP 5 2nd Edition
- Why a second Edition?
- Documents vs records
- Agility and tools
- Critical Thinking and CSA (Computer Software Assurance)
Audit Trail (Review)
- EU-GMP Annex 11 and Audit Trail
- Which systems require an Audit Trail?
- Audit Trail Review
- GAMP 5 2nd Edition and Audit Trail
IT Trends and Challenges
Introduction to Cloud Computing
- Cloud as part of IT Infrastructure
- Cloud Service models
- Opportunities and risks
AI – Artificial Intelligence
- Basics of AI, ML, and DL
- Life cycle of an AI-enabled System
- Innovation vs regulation
- Use cases
Cybersecurity
- Threats
- Security concepts
Leveraging Supplier Involvement
- What leveraging really means
- Common pitfalls (and how to avoid them)
- How to reduce duplicate efforts?
- Supplier audits
| ECA-Member*: | € 1890,- |
| Non ECA Member*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
Teilnehmerstimmen
Seminarprogramm als PDF
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