PIER in collaboration with EIPG are organising a webinar on the topic of 'Data Integrity' on Tues 11th December 2018 at 4pm GMT. The speaker is Dr Alessandro Regola who has extensive experience in GMP and quality systems. The session will be chaired by Dr Piero Iamartino, EIPG Vice-President, Technical and Professional Development.
Overview of Webinar: The presentation will cover the issue related to the integrity of GMP relevant data that the pharmaceutical industry has been struggling with for the past 5-7 years mainly due to violations recorded during Authority inspections to pharmaceutical (both API and drug product) manufacturing facilities. Most common and frequent compliance issues related to paper, IT or hybrid (paper+ IT) systems will be discussed. A recommended risk assessment and remediation approach will be presented, including the classification of affected system based on risk for the quality of the product and the patient health, the evaluation of the gaps and the prioritisation of corrective actions.
For further details on the webinar and how to register, see EIPG PIER webinar on Data Integrity_11th Dec 2018.