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Pullman Basel Europe

Nov 06, 2014 8:00 AM - Nov 07, 2014 5:30 PM

Clarastrasse 43, 4058 Basel, Switzerland

ISPE/DIA Workshop on Computer Systems Compliance “Maintain Data Integrity to Reduce Risk for the Patient”

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Session 1: DATA INTEGRITY AND A RISK-BASED APPROACH

Session Chair(s)

Breffni Kennedy Martin

Breffni Kennedy Martin

Managing Director

Regintel Ltd, Ireland

This opening session will provide an insight into the regulatory challenges facing the life sciences industry from the emergence and introduction of new technologies such as cloud computing and mobile applications/devices and the impact upon data integrity. It will also look at how we may adopt a risk-based approach to ensuring continued GxP compliance of computerised systems in this new environment.

Speaker(s)

Teri Stokes, PhD, MS, MT

Teri Stokes, PhD, MS, MT

GXP International, United States

Director, Quality Assurance Compliance

GAMP® 5 – Risk-based approach to GXP compliant computerised systems

Sion Wyn

Conformity Ltd, United Kingdom

Owner

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