Pharma Supply Chain: GDP Requirements and Certification for Logistics Vendors - Live Online Training
Tuesday, 28 September 2027 9 .30 - 16.45 h
Course No. 23184
Speakers
David Abraham
QRS-Associates
Dr Zvonimir Majic
IATA Senior consultant for Healthcare, Croatia
With practical examples and exercises
Target Group
Personnel of logistics service providers
Management personnel in pharmaceutical companies
Quality personnel in pharmaceutical companies
Wholesalers and distributors
Service providers involved in the distribution of medicinal products
Objectives
It is essential that medicinal products are not only manufactured in accordance with Good Manufacturing Practice (GMP), but that their quality and integrity are maintained throughout the entire supply chain. This is the purpose of Good Distribution Practice (GDP).
During this Live Online Training, the key GDP requirements for logistics service providers will be explained, including how these requirements are evolving and how they can be implemented effectively. Different certification options will also be discussed. Practical examples, exercises, polling questions and a Q&A session will ensure an interactive format.
Background
Good Distribution Practice ensures that the quality of medicinal products is maintained during storage and transport. The EU GDP Guidelines require manufacturers to control and supervise the supply chain, including wholesalers, transport companies and other logistics providers.
Many logistics activities are outsourced. Although transport companies do not require a wholesale distribution authorisation, they must comply with the GDP requirements relevant to their activities. However, they do not receive a GDP certificate.
An independent assessment against international GDP requirements can help logistics providers demonstrate that their Quality Management System complies with GDP expectations.
ISO certification may also support the improvement of processes and provide a competitive advantage. ISO 9001 offers a general quality management framework, but does not cover EU GDP requirements in sufficient detail. Companies using this framework should therefore integrate the relevant GDP requirements into their Quality Management System.
Programme
Mastering Supply Chain Risks
Understanding supply chain impacts
Threats, vulnerabilities and impacts
The role of Due Diligence
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
Applying supply chain learnings
Questions and Answers Session
Participants are invited to ask questions
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 EUR 1,190 Regular Fee EUR 1,290 APIC Members EUR 1,240 GDP Association Members 1,190 EU GMP Inspectorates EUR 645 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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