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Importers

MDR QMS Setup

QMS Implementation Planning

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Document Control

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Quality Manual

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Record Control

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Quality Objectives

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Training

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Planning

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Purchasing

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Identification Handling/ Storage

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Trend?

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Facility Control

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Environmental Control

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Risk Management

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CAPA Procedure

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Process Monitoring

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Distribution

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Management Controls/Review

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Complaint Handling

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FSCA/FSN/Recall

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Vigilance

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Importer Responsibilities

Economic Operator Procedure

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Complaint/Vigilance FSN/FSCA

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EUDAMED Registration Procedure

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Product Label Responsibilities

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Facility Requirements

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Train Distributors and Sub-distributor on Distributor requirements

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Identify Administrators / Job Descriptions

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Traceability

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Setup Receiving Inspection Requirements

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Record Retention

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Additional Documents

Additional Documents 1

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Additional Documents 2

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Additional Documents 3

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Additional Documents 4

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