Date:
December 03 - 04, 2024
December 05, 2024 (post-conference)
Language:
Location:
Abstract
The 17th official GAMP® 5 conference will take place from December 3-4, 2024 in Mannheim, followed by the post-conference on December 5, 2024 on the topics of data integrity, GxP in the cloud and artificial intelligence in the pharmaceutical industry. The event is aimed at managers and employees who are responsible for implementing the GAMP®5 requirements in the pharmaceutical and medical technology industry. The conference covers the entire pharmaceutical product life cycle, the GMP phase and accompanying processes. Participants will gain insights into current concepts, tools and systems for increasing efficiency as well as digitalization and IT compliance in the GMP and GLP area.
More details about the event can be found here.
Preview of the program
Day 1
- Welcome and introduction
- Keynote Annex 11 Update
- From data to product
- GLP / Concept Paper OECD Cloud in GLP
- Discussion rounds
Day 2
- News from the world of GAMP and VDI
- Use case digitization
- Digitization of GMP processes
- IT compliance from a QP perspective
- What the pharmacist expects functionally from new software, taking into account the changed regulatory requirements
- Panel discussion
- Cybersecurity risks and resilience: how do I prepare for an emergency?
- Audit Trail and IT Security in EU-GMP Annex 11 Draft
- Final discussion/concluding remarks
For us on site:
Christophe Girardey
Managing Director and Head of the CSV & QA department at wega Informatik AG.
He works as a CSV consulting expert in many different projects, mainly in German-speaking countries.
He has a particular focus on laboratory data systems (LIMS, chromatography data systems, laboratory execution systems) and supports customers in implementing the best solution from various perspectives (efficiency, compliance, data integrity).
He also supports many customers in the optimal use of the agile methodology in the GxP environment.