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Over the last years, the regulatory pressure regarding the integrity of GxP relevant data increases significantly. Not only the US-FDA but various regional and national authorities as well investigate with increasing rigour the handling of critical and GxP data.
Based on several case studies, this Webinar will make you confident with both integrity criterion as well as applicable regulatory requirements and expectations. Furthermore, this Webinar will also address the organisational interfaces between regulated user and its suppliers and service providers.
For which purpose?
Data life cycle
About data integrity
Integrity traps to avoid
Regulatory requirements / Annex 11 vs. 21 CFR 11
Data ownership and responsibilities
12 data integrity commandments
This webinar targets in particular executives and staff working in:
Quality units - QA and QC
Analytical and laboratory units
Manufacturing and process automation
Supporting IT personnel
Yves Samson, Kereon AG, Basel, Switzerland
Yves is founder of Kereon AG, Basel. He is member of GAMP Europe Steering Committees, chairman and co-founder of GAMP Francophone and edited the French version of GAMP 4 and GAMP 5. Within ISPE he was an active member of the working group “IT Infrastructure Compliance and Control”.