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Data Integrity and production systems: how to prevent the inspection observations on this subject?

Moderator A3P : Jean-Louis Jouve
facilitators: Thierry DUFRASNE - Baxter & Hervé CLUZEAUD - Assystem

Data integrity, paper or electronic format, has become a major issue for the drug industry and health products. This reason is highlighted in many comments from US and European regulatory authorities under the generic term "Data Integrity".
The proposed workshop aims to:
- Clarify the definition of that term and expectations of regulatory authorities on the subject,
- Assess, through an industrial case study oriented production systems, the various risks associated with the "Data Integrity"
- To propose the technical and human resources to manage those risks.

Consult the full program of the Congress // View A3P Congress program

 

 

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