Dr Zvonimir Majic
IATA Senior consultant for Healthcare, Croatia
Referierende
Shortcuts: compact learning units of 1–3 hours – perfect for a quick overview or a focused deep dive into a specific topic. Book online, receive access within minutes and benefit from 7 days of on-demand availability, giving you maximum flexibility in your day-to-day work.
Compact. Flexible. Immediately available.
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
Zielsetzung
Background
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 Shortcut will provide insights on how to ensure compliance in this important GDP aspect.
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 Shortcut will provide insights on how to ensure compliance in this important GDP aspect.
Programm
The aim of this shortcut 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
Weitere Informationen
The purchase process for the GMP & GDP Shortcuts is handled via the sales platform Digistore24 (www.digistore24.com). Please understand that it is not possible to place an order on account in this case.
By clicking the “Book now” button at the top right, you will be redirected to Digistore24. After successful payment, you will automatically receive a confirmation email from Digistore24 and an email from Memberspot (our streaming provider) asking you to register.
Afterwards, you will have access to the purchased video for 7 days.
Please note: The booking is valid only for the registered participants. The use by other persons is prohibited and constitutes an infringement of copyright.
Presentation and certificate:
Starting from the purchase date, the presentation will be available for you to download in Memberspot for 7 days. Afterwards, the participants can download a certificate of attendance.
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
Duration of the shortcut: 1h 30m
Recorded in August 2020
Please note:
When you click on “Register”, you will be redirected to www.digistore24.com. Once your payment has been successfully completed, you will immediately receive 7 days’ access to the Shortcut you ordered via the Memberspot streaming platform. We kindly ask for your understanding that payment by invoice is not possible.
When you click on “Register”, you will be redirected to www.digistore24.com. Once your payment has been successfully completed, you will immediately receive 7 days’ access to the Shortcut you ordered via the Memberspot streaming platform. We kindly ask for your understanding that payment by invoice is not possible.
Teilnahmegebühr
| Regular Fee*: | € 399,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
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Tel.: +49 6221 8444-0
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