David Abraham
QRS-Associates
Referierende
Dr Zvonimir Majic
IATA Senior consultant for Healthcare, Croatia
With practical examples and exercises
Zielgruppe
- 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
Zielsetzung
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.
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.
Programm
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
Weitere Informationen
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.
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.
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.
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.
The official conference language will be English.
Contacts
Questions regarding content:
Dr Markus Funk, +49 6221 84 44-40, funk@concept-heidelberg.de
Questions regarding organisation:
Ms Nicole Bach, +49 6221 84 44-22, nicole.bach@concept-heidelberg.de
Questions regarding content:
Dr Markus Funk, +49 6221 84 44-40, funk@concept-heidelberg.de
Questions regarding organisation:
Ms Nicole Bach, +49 6221 84 44-22, nicole.bach@concept-heidelberg.de
Datum & Uhrzeiten
Tue, 28 Sep 2027, 09:30-16:45 h
All times mentioned are CEST.
Teilnahmegebühr
| ECA-Member*: | € 1190,- |
| Regular Fee*: | € 1290,- |
| EU/GMP Inspectorates*: | € 645,- |
| APIC Member Discount*: | € 1240,- |
| GDP Association Member Discount*: | € 1190,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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Tel.: +49 6221 8444-0
E-Mail: info@concept-heidelberg.de
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