Date:
November 16, 2023
Language:
Location:
Abstract
ISPE France is hosting a conference in Lyon on November 16, 2023, on the topic of data integrity: approaches and solutions, benefits, challenges, opportunities for improvement, etc.
For more than ten years, regulatory authorities have been keeping up the pressure on the industry regarding data integrity. However, experience shows how difficult it is to implement effective strategies to support data integrity.
Data integrity is not limited to electronic records; therefore, the necessary strategies must take into account all relevant records and documents in all their forms—paper, electronic, hybrid, etc.
Similarly, the implementation of data governance is not only desirable but is also expected by the authorities. Such data governance requires the effective and controlled development and implementation of supporting 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 Regulatory Inspections (GLP, GMP)
- Analysis of Several "Warning Letters"
- Data Integrity: A Challenge
- "Human Error" 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 on many different projects, primarily in German-speaking countries.
He places a special focus on laboratory data systems (LIMS, chromatography data systems, Laboratory Execution System) and helps customers implement the best solution from various perspectives (efficiency, compliance, data integrity).
In addition, he helps many clients make the most of agile methodologies in a GxP environment.