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Cold Chain Management and its Validation - Webinar Recording

Seminar-Nr. 18209A

Referent:innen

Dr Zvonimir Majic

Dr Zvonimir Majic

IATA Senior consultant for Healthcare, Croatia

Hintergrund

Growing regulatory expectations regarding pharmaceutical storage, transport and cold chain management are forcing the pharmaceutical industry to challenge their current practices.
For temperature sensitive products, different regulations apply. For example, the EU-GDP Guidelines (2013/C 343/01) state that “qualified equipment (e.g. thermal packaging, temperature-controlled containers or temperature-controlled vehicles) should be used to ensure correct transport conditions are maintained between the manufacturer, wholesale distributor and customer.” According to USP General Chapter 1079 “vehicles designated to provide appropriate temperature range for the product being shipped should be used.” More regulatory documents around the globe are emphasizing need of having qualified shipping systems in place. Besides the logistics service providers, packaging (active or passive), transport modes and lanes and vehicles require risk assessment and qualifications. This webinar will provide insights on how to ensure compliance in this important GDP aspect.

Zielgruppe

This webinar addresses itself to all managers, supervisors and other staff members who are involved in pharmaceutical cold chain management. Those are e.g. employees from the following industries:
  • Pharmaceutical manufacturers (e.g. logistics and QA)
  • Drug wholesaler
  • Logistics companies
  • External warehouses
  • Further service providers in the distribution of pharmaceuticals

Technical Details

To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.

Timing and Duration:

When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.

In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.

Training Course Documentation and Certificate:

The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.

Programm

The aim of this webinar is to give participants a comprehensive yet compact overview of cold chain management and its validation. The following topics are addressed:
  • Regulatory requirement
  • Qualification vs. validation
  • Cold chain management system components
  • Qualification of logistic service providers
  • Qualification of temperature-controlled shipping system for pharmaceutical products
  • Transport equipment qualification
  • Risk evaluation, quality control and monitoring
Recording from 24.08.2020
Duration of recording: about 1.5 h.

ECA-Member*: € 199,-
Regular Fee*: € 249,-

Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.

* auch unkompliziert per Kreditkarte bezahlbar
American Express Visa Mastercard

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Teilnehmerstimmen - das sagen andere über unsere Seminare:

Guter, breit gefächerter Überblick mit interessanten Verknüpfungen zur Praxis,
welche die Theorie super veranschaulicht.”
Marina Kicoranovic, Labor Hartmann GmbH
GMP/Basis-Einstiegsschulung (B 14), September 2023

Die Referenten waren sehr gut! Sie haben sehr klar gesprochen, nur sehr wenige englische Begriffe
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Astrid Gießler, Regierungspräsidium Karlsruhe
Live Online Seminar - Basiskurs Computervalidierung & Datenintegrität im GxP Umfeld (B 3), Juni 2023

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GMP-Basisschulung (B 1), Juni 2023

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