GDPMD & Regulatory Compliance

About Course

Course Overview
This programme introduces Good Distribution Practice for Medical Devices (GDPMD) and the regulatory controls needed to manage storage, transportation, traceability, complaints, and post-market responsibilities in the medical device supply chain.
The course focuses on the responsibilities of authorized representatives, importers, and distributors, and on how to build a compliant quality system around medical device distribution activities.

Who Should Attend
– Authorized representatives
– Importers and distributors
– Quality and regulatory personnel
– Warehouse and logistics managers

Training Method
– Lecture
– Case review
– Document example review
– Discussion

Course Modules
– Medical Device Regulatory Framework and GDPMD Scope
– Quality System, Premises and Storage Controls
– Document Control, Traceability and Distribution Records
– Complaint Handling, Vigilance and Recall Readiness
– Self-Inspection, Internal Audit and Management Review