GDP Champion Training – Dublin | 3-Day course

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– 2 year certification –

The IEA’s Good Distribution Practice Passport (GDP) plays a key role in assuring security in the life sciences supply chain through compliance and understanding risks and responsibilities. The GDP Champion is the key contact point on all compliance and quality aspects of GDP practices along the supply chain at each individual premises.

If you are involved in the manufacturing, transportation or storage of pharmaceutical products and need a better understanding of pharmaceutical supply chain compliance the GDP Champion is for you.

 

Date: Tuesday 13th – Thursday 15th November 2018

Time: 9:30am – 5:00pm

Venue: Crowne Plaza, Santry

Cost: €1850 IEA members / €2250 Non members

Book Now: Contact Niamh Burke at training@irishexporters.ie by 6th November

 

Lunch, tea & coffee breaks included

 

What is covered?

  • Key quality components of GDP explained in a practical way
  • Self inspections / Audits
  • Standard Operating Procedures (SOPs)
  • GDP Staff training
  • Recall / Returns
  • Facility & warehouse layout
  • Temperature controlled logistics

Who should attend?

  • Logistics companies
  • Freight forwarders
  • Haulage companies
  • Supply Chain managers within life sciences companies

Course outline

Day 1:

GDP Introduction

Legislation / Quality Systems

Returns, Self-Inspections, Counterfeit

GDP Summary

Quiz Q&A

Day 2:

Supply Chain Traceability & Bona fides

Receipt, Storage and Distribution

Temperature Controlled Logistics

TCL – Supply Chain Integrity

Summary Q&A

Day  3:

Overview / Summary of GXP principles

Why quality systems?

What is a Quality System?

Where does ISO fit?

SOPs

Documentation

Change control

CAPA

Regulatory Audits and Self-Inspection

Assessment

 

For help, support or further information, please contact Niamh Burke on 01 661 2183 or training@irishexporters.ie

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location Location location Date time Time
Crowne Plaza, Santry November 15, 2018 Full Day: 9:30 am - 5:00 pm

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