home
   
  COURSE 7

Cold Chain



Target Group

Staff who work in pharmaceuticals or active pharmaceutical ingredients production e.g. in the warehousing and logistics department as well as its service providers.

Prior Knowledge:
No prior GMP knowledge is required.

Languages available:
Dutch, German and English.

Implementation:
Using videos from GMP facilities!

Study Time:
1 hour

Questions to:
Phone +49(0)6221 / 84 44 0 - e-Mail: info (at) concept-heidelberg.de

BOOK THIS COURSE (€ 75)

WATCH DEMO

Do you want to book this course for more than 10 employees?
Send us an inquiry with the title of the course and the number of participants. We will make you a special offer.


Details

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.

Certificate
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 hour.

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
    Possible problems
    Quarantaine
    Stay alert
    Labeling

Chapter 4: Storage

    Correct location and temperature
    Refrigerator alarm
    Temperature registration
    Checking the quality by the Quality department

Chapter 5: Order process

    Handling cool products
    Possible problems
    Active and passive cooling
    Validation

Chapter 6: Transport

    Correct temperature
    Temperature check
    Recording
    Reporting

Chapter 7: Delivery

    Deviating situations
    In-night delivery
    Coolers
     

Chapter 8: Conclusion

    Summary of the most important issues

    Test

BOOK THIS COURSE (€ 75)