Systems GxP, data integrity, quality, validation

Data integrity of computerized systems (1 day)

Data integrity of computerized systems (1 day)

Knowing how to independently carry out a GxP risk analysis on all types of systems and articulated around regulatory requirements (GMP, Part 11, ICH Q9, Part 820, Data Integrity)…

Medical Device Software GxP Compliance (1 day)

Medical Device Software GxP Compliance (1 day)

Know and understand the applicable requirements for GxP regulatory compliance of computerized medical devices and for computerized systems participating in the Quality of medical devices…

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91300 MASSY
Tel : +33 (0)1 69 35 05 43
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