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GDP Awareness Training
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GDP Awareness Training

Good Distribution Practice awareness for everyone involved in the storage, handling and distribution of medicinal products.

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Course content

GDP Introduction

  • Pre-assessment
  • Why Must We Regulate
  • What is Good Distribution Practice
  • The Definition of Pharma Wholesaling
  • Who and what is an RP
  • What is an RPi
  • Who are the MHRA
  • GDP Introduction - module assessment

Quality Management Systems (QMS)

  • What is a Quality Management System
  • What must a QMS contain and ensure
  • Your Responsibilities
  • Quality Risk Management - the Process
  • Quality Management Systems (QMS) - module assessment

GDP Guidelines 2013/C 343/01

  • Chapters of the GDP Guidelines
  • Guidelines Ch 3 - Premises and Equipment
  • Guidelines Ch 4 - Documentation
  • Guidelines Ch 5 - Operations
  • Guidelines Ch 6 - Complaints and recalls
  • Guidelines Ch 9 - Transport
  • GDP Guidelines 2013/C 343/01 - module assessment

Good Documentation Practice

  • Good Documentation Practice
  • Data Integrity - Keeping Good Records
  • Good Documentation Practice - module assessment

Deviations, CAPA and Change Control

  • Definition of a Deviation
  • What is a CAPA
  • What is a Change Control
  • Deviations, CAPA and Change Control - module assessment

Final assessment

  • Final assessment