(7) Maturity Café
Tuesday, September 26
11:40 AM - 03:40 PM
Live in Berlin
Less Details
Over or under 5 years?
Are there currently any practical improvements seen by AI/ML in your plants? Or if not, how do you see it’s applications in the future, how will it help you once you have the data?
If it was a phased approach (e.g. eLogs > eBR > interfaces > pharma 4.0 technologies), which stage was the most difficult and which had the biggest payoff?
For processes that require a high degree of flexibility, have you seen a reduction in flexibility with MES and have the benefits outweighed the loss? (e.g. clinical phase II or III).
Are the technology/quality systems ready for enabling flexible MES solutions for these product stages? What makes them so?
IT/OT Business Systems Specialist
Supporting Laboratory (LIMS) & Manufacturing (MES, Track & Trace, Automation) Software and Systems in GxP regulated environments.
Experienced Data Integrity Specialist.
Incident & Problem Management
Life-Cycle Management
Software Validation, Configuration & Deployment. (Gamp5, CSV)
Systems Maintenance
I have a strong background in Support and Administration of Regulated Systems in GxP manufacturing including Projects, Upgrades, Critical Incident Management and security patching.
Additionally, I have Knowledge & Experience in Data Integrity and Implementing Data Integrity approaches on a site wide level.
I have experience in following GxP, Gamp5 & CSV procedures to ensure all systems are implemented in compliance with current regulatory requirements. I am used to working as part of a cross-functional teams to help ensure the delivery of projects and support the day-to day administration of Global & Site systems.
I have experience in drafting, devloping and excicuting various documentation, including SOP’s, Work Instructions, IQ/OQ/PQ & Knowledge Articles (KB’s). Additionaly I have experience in drafting, delivering and implementing site training.
I am currently working as MES Systems Administrator (MODA-ES) for Lonza NL