Introduction to Good Distribution Practice (GDP) - Live Online Training
GDP in Practice – Core Requirements for Beginners
7./8. Oktober 2026
Course No. 22764
Speakers
Dr Sue Mann
Sue Mann Consultancy
Dr Zvonimir Majic
IATA Senior consultant for Healthcare, Croatia
Kane Edgeworth
Biomap
Applying GDP throughout the Pharmaceutical Supply Chain – Storage, Transport and Cold Chain
Target Group
Employees newly assigned to GDP-relevant roles within pharmaceutical distribution
Supply chain and operations professionals seeking to strengthen their GDP understanding
Quality Assurance personnel with new or expanded GDP responsibilities
Newly established or growing GDP organisations and service providers
Objectives
This Live Online Training provides a comprehensive overview of Good Distribution Practice (GDP) requirements applicable to the pharmaceutical supply chain, with a focus on storage, transportation and cold chain management of medicinal products within the European regulatory Framework.
Participants will gain a clear understanding of the legal and regulatory background of GDP, including its relationship to GMP, and learn how GDP requirements are interpreted by authorities during inspections. The training highlights current regulatory expectations, recent developments and emerging risk areas in pharmaceutical Distribution.
Programme
Welcome and Introduction
Introduction to the training agenda and the speaker’s team
Introduction to the ECA GDP Association (GDPA)
Purpose and scope of the GDPA
Documents developed by the GDPA
Live poll to assess participants’ GDP experience and Background
GDP Rules and Regulatory Framework
What is Good Distribution Practice (GDP)?
Relationship between GDP and GMP
Overview of the EU GDP Guidelines
Roles and responsibilities in the pharmaceutical supply chain
Reference to additional guidance (e.g. ECA Roadmap to GDP)
Understanding the Pharmaceutical Supply Chain
Selection of supply routes
Key stakeholders and handover points
Basic process mapping of a supply chain
Fundamental QMS elements in distribution
Where GDP risks commonly occur
GDP-Compliant Storage – Expectations and Common Pitfalls
Storage types and temperature ranges
Basic requirements for GDP-compliant storage facilities
How to set up an adequate storage facility
Introduction to temperature monitoring
Typical storage-related inspection findings
Common mistakes in warehouse operations
Best Practices in Transport and Logistics
How to implement the requirements and stay efficient
Managing 15-25 °C and 2-8 °C transportation
Challenges that different modes of transportation introduce to pharmaceuticals
Introduction to Cold Chain Management
Principles of cold chain management
Monitoring versus validation
Basic concepts of route qualification
Data collection and basic evaluation principles
Typical cold chain risks and failures
Case Study on Temperature Mapping
Protocol preparation
Seasonal variations
Impact tests
Results and reporting
Supply Chain Security
Anti-counterfeiting strategies
What the agencies can do
What industry can do
Compliance issues
Deviations & Excursions
What is a deviation? What is a temperature excursion?
Typical deviation scenarios in pharmaceutical distribution
Immediate actions and escalation pathways
Documentation and basic investigation principles
Introduction to CAPA thinking
What to Expect During a GDP Inspection
Purpose and structure of a GDP inspection
Importance of careful planning for a GDP inspection
Roles and responsibilities during an inspection
Behaviour and communication during inspections
Data Integrity in GDP Activities
What data integrity means in a GDP context
Why data integrity is a growing GDP focus
Temperature data, alarms and manual records
Introduction to ALCOA+ principles
Examples of data integrity failures in GDP
Import and Export
Import and export from a GDP perspective
Regulations impacting import and export (e.g. Annex 21, MRA)
Political developments impacting import and export (e.g. Brexit, trade Embargos)
Further Information
Technical Requirements We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Fees (per delegate, plus VAT) ECA Members € 1,890 APIC Members € 1,990 Non-ECA Members € 2,090 EU GMP Inspectorates € 1,045 The conference fee is payable in advance after receipt of invoice.
Presentations/Certificate The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
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