Dr Zvonimir Majic
IATA Senior consultant for Healthcare, Croatia
Referierende
Important: Deadline is 12 noon on 18 August 2020.
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.
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 Requirements
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
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
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