EIPG’s and PIER’s next webinar, presented by Alessandro Regola, will cover the GMP requirements and the practical implementation of a management system for quality related documentation. After an introduction referencing the relevant GMP norms and guidances, the different types of documents will be described with their function in the Quality System and their requirements. Paper and electronic based systems will be described with their peculiarities. The presentation will continue with a description of the most frequent deficiencies in documentation management, including some examples of Authorities’ observations during inspections (observations from FDA, EMA and MHRA inspections will be presented). Finally, some best practices will be presented, combining GMP compliance and efficiency in documentation management and recommended by the speaker based on his experience.
This is an event for members of EIPG member organisations, Contact your national association EIPG representative for further information.