Course Description
Air Freight logistics is an open cold chain and this is a fact. The entire logistic chain is made of different actors, working together in a complex commercial relationship matrix maintaining the pharmaceutical integrity within the required temperature requirements.
Many variables need to be managed to be successful. Critical control points must be risk assessed and controlled. We will analyze those critical control points and the involved documents, special handling codes and labels.
We are going also to discuss the GDP requirements and which chapters are impacting to logistic providers part of the air freight logistic chain.
The scope of this session is to explain the main requirements coming from the pharmaceutical industry and how they impact the logistic company.
Additionally, you will see what active and hybrid containers are. What differentiates passive packaging system and what is the scope of a thermal cover.
We will give an answer to different kinds of different temperature monitoring systems, and have a look into what different devices are on the market and what are they for.
The final part of the training will go through risk management basic requirements and how an FMEA method should be used and implemented correctly.
What you'll learn
- Raise the knowledge of the Good Distribution principles
- Complexity of the distribution chain
- QMS requirements in GDP
- Personnel and pharma responsible person responsibilities
- Training needs
- Infrastructure and equipment requirements
- Operations
- Supplier Management requirements
- Internal audits
- Transportations
- Why should we protect pharmaceuticals?
- What kind of damages we can do?
- Documents involved in the handling of pharmaceuticals in airfreight
- What is the PIL label
- Critical control points in the airport handling
- Special handling codes for the airfreight Industry regarding pharmaceuticals
- Tarmac protections
- Different types of active containers (ULD) and hybrid containers
- Passive packaging systems
- What are thermal covers and what are their limits
- Various types of instruments for recording of temperatures in the pharmaceutical cold chain
- Differences between passive and active devices and regulations in air freight
- Temperature monitoring systems for cold rooms and shipments
- How to read a temperature graph
- Know the GDP and CEIV "requirements" of a monitoring system
- What is risk management
- What is the Failure Mode and Effect Analysis
- Probability, Severity, and Detention action
- Risk mitigation
- How to apply those methodologies to an airfreight operation, infrastructure, and critical equipment
To Whom it is addressed
Logistic Managers
Supply Chain Managers
QA Managers
IATA CEIV Pharma Responsible Persons
Warehouse Managers