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Inspection Preparation 9 th January 2017

Inspection Preparation 9 th January 2017. 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

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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

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