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Cold Chain is a common expression for a temperature-controlled supply chain. This should guarantee one common temperature range for pharmaceutical products which need to be handled, stored and transported at a defined temperature or temperature range. A common temperature range for a Cold Chain in pharmaceutical industries is 2 to 8 °C. But also other specific or dedicated temperature ranges are possible. During the whole supply chain, these ranges should not be exceeded. Interruption of the cold chain might have a negative influence on the quality, safety or efficacy of a medicinal product.
Guides, Guidelines and initiatives from various agencies like EMA, FDA, WHO and USP lead the way and define expectations and requirements. How these can be implemented into daily work is elaborated in this module.
The attention of the student is being drawn by means of a practical cases and examples. Possible consequences of incorrectly cooled medicinal products are explained. And it is explained how these deviations could occur and how they can be avoided.
The chapters emphasise the importance of the Cold Chain, give information about what employees should do to maintain the Cold Chain and treat possible problems. This information has been split up in several process steps/departments of the whole supply chain (from the manufacturer
to the customer).
By means of questions, feedback, pictures and a large amount of video fragments all important aspects of are treated. Short and playful practical cases keep the students alert and give them a pleasant variation.
Attendance certificate from CONCEPT HEIDELBERG
Costs - individuals
€ 75,- plus VAT.
Costs - company licence
Companies which yearly train more than 50 employees can aquire a company licence.
Depending on the use, courses can be carried out for under € 30,- per training
Chapter 1: A practical case :
Serious consequences of incorrect temperature of a medicine
Influence of the wholesaler
Chapter 2: Cold Chain
What is the Cold Chain?
Deep frozen products, fridge products, products that have to be kept cool and
products that has to stay on room temperature
Chapter 3: Newly arrived good
Handling cool products
Chapter 4: Storage
Correct location and temperature
Checking the quality by the Quality department
Chapter 5: Order process
Handling cool products
Active and passive cooling
Chapter 6: Transport