Inspection Preparation 9 th January 2017 - PowerPoint PPT Presentation

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Inspection Preparation 9 th January 2017

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  1. Inspection Preparation 9th January 2017

  2. Scope • Develop a toolkit of inspection preparation checklists, lessons learned and other resources that are available in the public domain • As part of the toolkit, we set out to define roles and responsibilities • Work began: 29 April 2016 • Work completed: 02 November 2016

  3. Members of the Group

  4. Gatheringbestpractices • List of tasks/activitiesperformed to prepare for inspectionwerelisted • Roleswerealsoadded, but the rolesvaried a lotbetweencompanies • Decision was made to develop a RACI thatcanbeadapted to the size and roles of each organisation

  5. Inspection Readiness RACI Columns added to beused for organisation-specificroles Tasksaregrouped to easeoverview Definition of key elements; used to ensurecommonunderstanding of the content of the task Short description of the actualtask or process step Indication of whether the task is relevant for eTMF or paper