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Temperature-Sensitive Pharmaceuticals – Transport and Vehicle Qualification - Live Online Training

Thursday, 10 October 2024 9 .00 - 12.30 h

Seminar-Nr. 21243

All times mentioned are CEST.

Zielsetzung

This Live Online Training aims to give participants a comprehensive yet compact overview of expectations concerning the transportation of products requiring special conditions. The focus will be on the requirements for the transport of temperature-sensitive products.

General aspects of road transport and air fright at cold chain conditions will be discussed. Furthermore, vehicle qualification and the effective mapping of vehicles will be covered. Q&A sessions will follow both lectures. Thus, take advantage of this opportunity to ask your questions.

Hintergrund

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.

The distribution of temperature-sensitive pharmaceuticals is extremely challenging. The EU GDP-Guidelines (Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use) require that if temperature-controlled vehicles are used, the temperature monitoring equipment used during transport should be maintained and calibrated at regular intervals. Temperature mapping under representative conditions should be carried out, taking into account seasonal variations. For temperature-sensitive products, qualified equipment (e.g. thermal packaging, temperature-controlled containers or temperature controlled vehicles) should be used to ensure correct transport conditions.

The approvals of various COVID-19 vaccines in many countries at the beginning of 2021 illustrated the importance of distribution of temperature-sensitive medicinal products – and the challenges involved. For example, how must these vaccines – but also any other temperature-sensitive product in general – be transported to get safely from the production sites to the storage and distribution centres and then on to the local vaccination centres?

The specific packaging, transport, handling and storage requirements as well as the transport routes may differ depending on the type of pharmaceutical product. In any case, transport companies must take special safety precautions for the transport of temperature-sensitive pharmaceuticals. The products are often not only very valuable, but also particularly sensitive. Damages can quickly lead to a total loss, as in case of doubt, the entire load must be destroyed. In addition, there are risks such as interruption of the cold chain. Therefore, the products may only be distributed with controlled packaging solutions and in special vehicles that are appropriately qualified and whose temperature is monitored permanently.

Zielgruppe

This Live Online Training was developed for managers, executives, Responsible Persons (RPs), technical staff and other employees from companies involved in the distribution and supply of temperature-sensitive pharmaceutical products.

It will be of interest in particular for personnel from the following departments: ƒ
  • Quality Assurance ƒ
  • Validation ƒ
  • Engineering ƒ
  • Logistics ƒ
  • Cold Chain ƒ
  • Regulatory Compliance

Technical Requirements

We use WebEx for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings 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.

Programm

Temperature-Sensitive Pharmaceuticals – Transport and Vehicle Qualification - Live Online Training

Gesamtes Programm als PDF herunterladen

Welcome and Introduction
(Dr Markus Funk)

Temperature-Controlled Transports of Medicinal Products
(Peter Kralinger)
  • Transport process design approach
  • Optimization: insulation, freight cost, risk reduction
  • Systems
    - Passive cooling
    - Thermohood
    - Containers for wide body aircrafts
  • Process risk assessment
  • Content of a quality agreement
  • Dataloggers
Vehicle Qualification
(Kane Edgeworth)
  • Regulatory landscape
  • Qualification & validation
    - Definitions
    - Matrix approach
    - Project planning & design
    - IQ/OQ/PQ
    - Calibration
  • Vehicle mapping case study
Questions and Answers Sessions
(Peter Kralinger and Kane Edgeworth)
  • Participants are invited to ask questions

ECA-Member*: € 490,-
Regular Fee*: € 590,-
EU/GMP Inspectorates*: € 490,-
APIC Member Discount*: € 490,-

Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.

* auch unkompliziert per Kreditkarte bezahlbar
American Express Visa Mastercard

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