Date:
November 16, 2023
Language:
Location:
Abstract
ISPE France is organizing a conference in Lyon on 16 November 2023 on the subject of data integrity: approaches and solutions, gains, problems, opportunities for improvement, etc.
For more than ten years, regulators have kept up the pressure on the industry with regard to data integrity. However, practice shows how difficult it is to implement effective strategies to support data integrity.
Data integrity is not limited to electronic records; therefore, the required strategies must consider all relevant records and documents in all their diversity - paper, electronic, hybrid, etc. - must be considered.
Similarly, the introduction of data governance is not only desirable, but also expected by the authorities. Such data governance requires the effective and controlled development and implementation of accompanying processes.
Learn more about the event here.
Our Professional Contribution
When: Thursday, November 16, 2023 at 1:45 p.m.
Analytical laboratories at the center of official inspections (BPL, BPF)
- Analysis of some "Warning Letters"
- Data integrity: a challenge
- "Human factor" and paper as sources of error
Our Speaker:
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.