Distribution of Medical Devices, including in vitro diagnostic Medical Device

Agenda

Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medical devices is maintained throughout the supply chain.

The minimum standards for GDP have increased. The  Regulation (EU) 2017/745 on medical devices  and 2017/746 on  In vitro medical  have placed greater responsibility on distributors of these devices

Module 1  Regulatory Compliance including Pharma and Medtech

Module 2  Quality Management / Systems

Module 3  Premises –design 

Module 4  Documentation (Including records)

Module 5  Recalls / Returns

Module 6  Transportation (Including Outsourced activities / Sub contractors)

Module 7  Temperature controlled requirements

Module 8  Validation of a Supply Chain

Module 9  SLA / SOP writing

Module 10  Deviations / CAPA’s

Module 11  Pre – Audit Inspection procedures

Learning Objectives                                                                                                                     If you are involved in the Manufacturing, Transportation or Storage of Medical Device products and need a better understanding of your responsibilities to  MDR 2017/ 745 and 2017/746 to ensure supply chain compliance? If so, this training course is for you.