Pharma Supply Chain - GDP Requirements and Certification for Logistics Vendors - Live Online Training
Thursday, 2 October 2025 9 .30 - 16.45 h
Seminar-Nr. 21763
Referent:innen
David Abraham
QRS-Associates
Dr Zvonimir Majic
IATA Senior consultant for Healthcare, Croatia
All times mentioned are CEST.
Zielsetzung
It is of key importance that medicinal products are not only made to a high quality in accordance with Good Manufacturing Practice (GMP), but that the quality and integrity of these products are maintained through the entire supply chain to the patient. This is where Good Distribution Practice (GDP) comes into play.
During this Live Online Training, well-experienced speakers will share their expert knowledge about all relevant aspects regarding the GDP requirements for logistic vendors. You will learn how these requirements evolve and how they can be implemented efficiently to bring and keep your organization in compliance with the GDP regulations. Furthermore, different certification options for logistic vendors will be discussed. Practical examples and exercises (including polling questions) and a Q&A session ensure interaction and that all questions are answered.
Hintergrund
Medicinal products are subject to special regulations for storage and transport. Good Distribution Practice (GDP) is the part of quality assurance that ensures that the quality of medicinal products is maintained at all stages of the supply chain.
The EU GDP-Guidelines are intended to ensure control of the distribution chain and consequently maintain the quality and integrity of medicinal products. Each manufacturer of a medicinal product needs to control and supervise the supply chain (wholesaler, transport and distribution companies etc.) of the finished products.
In the supply chain, many logistic activities are outsourced to service providers, e.g. logistic vendors. Transport companies do not need to hold a wholesale distribution authorisation to transport medicinal products. However, they should follow the parts of the GDP guideline relevant to their activities. Therefore transport companies need to follow GDP but will not receive a GDP certificate.
An independent assessment of compliance against international GDP requirements could be an effective way for logistic vendors to establish that their Quality Management Systems (QMS) align with the GDP requirement.
‘ISO’ is an abbreviation for the International Organization for Standardization, an independent, non-governmental international organization. There are a variety of ISO standards that transport and logistic companies can implement. Achieving an ISO certification means implementing a management system that improves the processes and procedures. Before signing a contract, a standard question may be about the type of certificates the company holds. In this way, quality standards can help to gain a competitive advantage in the transport and logistics sector. ISO 9001 is a generic quality management system providing a good framework for any organisation. However, the EU GDP expectations are not clearly detailed in this standard. It is therefore recommended that companies using the ISO framework incorporate the specific GDP requirements to ensure a compliant and workable QMS is available for the company.
Zielgruppe
This Live Online Training is aimed at all personnel of logistic vendors, but also to management and quality personnel from pharmaceutical companies, wholesalers, distributors and service providers involved in the distribution of medicinal products.
Date & Technical Requirements
Date
Thursday, 02 October 2025, 09:30 – 16:45 h (CEST)
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.
Management of supply chain security measures (TSM)
Quality and Risk Management Systems
QRMS procedures – customer focus and compliance requirements
Risk management – risk assessment of lanes, cross dock operations, transport mode and shipping systems (active, passive), transport vehicles and Containers
Quality agreements and SLA requirements
Supplier management
Audits
KPIs and performance Management
Standards and Guidance in Supply Chain
Supply Chain Standards
GDP meets ISO
Certification and selection of logistics suppliers
Building mitigation into your QMS
GDP Provisions for Transport, Handling and Storage of Time and Temperature sensitive Pharma Products in Supply Chain
Specific provisions and requirements for air, ocean and road transport
Specific requirements for in-transit storage premises and cross docks
Certification requirements and industry best practices
Continuous monitoring and improvement programs for logistics
Monitoring technologies and requirements
Practical Examples / Exercises (Dr Zvonimir Majic and David Abraham)
Applying supply chain learnings
Questions and Answers Session (Dr Zvonimir Majic and David Abraham)
Teilnehmerstimmen - das sagen andere über unsere Seminare:
„Flüssiger Vortrag, neue Aspekte wurden kommuniziert.“ Rainer Tryankowski, DRK-Blutspendedienst Rheinland-Pfalz und Saarland Webinar GDP Update 2025 März 2025
„Sehr guter Überblick über die aktuellen GDP Themen. Sehr kurzweilig.“ Juliana Dodillet, Pharma Resources GmbH Webinar GDP Update 2025 März 2025
„Sehr ausführliche Erklärung“ Jacqueline Buckel, UNITAX-Pharmalogistik GmbH Webinar GDP Update 2025 März 2025
„Sehr gut: praxisorientiert; Präsentation logisch nachvollziehbar“ Gabriele Unger, Astro-Pharma GmbH Webinar GDP Update 2025 März 2025
„Sehr informativ und umfangreich, aber immer auf den Punkt gebracht“ Jasmine Merz, Peppler GmbH Webinar GDP Update 2025 März 2025