Introduzione
Good Distribution Practices (GDP) for Medicines and Medical Devices
Good Distribution Practices (GDP), as defined in the EU Guidelines on GDP (2013/C 343/01), ensure that the quality and integrity of medicines and medical devices are preserved throughout the supply chain. Poor understanding or incorrect application of GDP can lead to product quality failures, regulatory findings, supply disruptions, and serious risks to patient safety.
This course provides a clear, practical, and inspection-focused understanding of GDP requirements for medicines and medical devices.
Participants will learn how to translate regulations into effective quality systems and daily operations, strengthening compliance across warehousing, transport, and outsourced activities.
Programme
This 8-hour interactive training covers GDP from regulatory foundations to operational execution, combining compliance expectations with real-world application.
Day 1 – Regulatory Framework, Quality Systems & People (4 hours)
Focus on EU GDP requirements and the fundamentals of a GDP-compliant Quality Management System, with a brief comparison to U.S. regulations.
Key topics include:
- GDP documentation and data integrity
- Change control as a risk-management tool
- Deviations, complaints, non-conformities and CAPA
- KPIs and performance monitoring
- Senior management responsibilities
- Self-inspections and audit readiness
- Personnel qualification, training and awareness
Day 2 – Operations, Warehousing & Transport (4 hours)
Application of GDP principles to day-to-day distribution activities, with a strong operational focus.
Key topics include:
- Warehouse operations and product handling
- Supplier, broker and customer qualification
- Returns, recalls and market withdrawals
- Warehouse qualification, maintenance and pest control
- Counterfeit medicines and medical devices
- Outsourced activities and contractor oversight
- Transport qualification, route validation and temperature control
- Transport deviations and incident management
This course is designed for professionals involved in the distribution, storage and transport of medicines and medical devices, who are responsible for ensuring compliance with Good Distribution Practices (GDP), including:
- Wholesalers and distributors (Responsible Persons, Quality and Operations Managers)
- Pharmaceutical and medical device manufacturers overseeing distribution or outsourcing
- Logistics and transport providers handling regulated healthcare products
- QA, Regulatory Affairs and Supply Chain professionals
- Warehouse managers and supervisors
- Professionals preparing for GDP audits or inspections
Participant experience
The course is suitable for both experienced professionals looking to refresh or consolidate their GDP knowledge and newcomers seeking a structured and practical introduction to GDP requirements.
The workshop follows an interactive and practice-oriented approach, using real examples from pharmaceutical, medical device, and healthcare logistics environments to illustrate regulatory expectations and common inspection findings.
Docente/i
Maria Àngels Moral
Senior Quality professional with 12+ years of experience in regulated pharmaceutical environments, specialized in Quality Management Systems (QMS), GDP compliance, and continuous operational improvement. Strong background in pharmaceutical distribution (including medicines, medical devices and foods for special medical purposes), supplier oversight, inspection readiness, and global quality governance, complemented by extensive experience in scientific and corporate communications within global life sciences organizations.
Online Training – 2 modules
MODULE 1 | 06 July 2027 from 2:00 pm to 6:00 pm CEST
MODULE 2 | 08 July 2027 from 2:00 pm to 6:00 pm CEST
Some days before the online training you will receive all details about the connection.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 930,00* (until 15 June 2027)
Ordinary: € 1.095,00*
Freelance – Individual – Academy – Public Administration: € 630,00*
* for Italian companies: +22% VAT
The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Newsletter
Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.
