Pre-Course Reading Material Exclusively for Participants of "GDP for Beginners"

Everybody involved in pharmaceutical storage, transportation, cold chain and distribution activities needs to know at least the basics of GDP. Therefore, the ECA has developed the Live Online Training "GDP for Beginners". The next course will take place on 31 January / 01 February 2024. During the training, you will get to know and discuss all relevant aspects regarding the current GMP and GDP requirements and latest developments in storage, transportation and cold chain management of medicinal products. You will learn how these requirements evolve and how they can be implemented efficiently.

All participants will exclusively receive a pre-course reading material. The package developed by Dr Zvonimir Majic from Teva Pharmaceutical Industries Ltd. consists of four documents with the following content:

Cold Chain Management and its Validation (14 pages)

• Regulatory requirements
• Good Distribution practice inspections
• Cold Chain Management System Components
• Qualification of Temperature-controlled shipping systems for pharmaceutical products

Best Practices in Transport and Logistics (10 pages)

• Active and Passive shipping systems and transport equipment

Shipping Stability (14 pages)

• Shipping process design and Critical Control Points
• Shipping process risk identification and assessment (FMEA)
• Process deviation handling, CAPA and continuous improvement

Pharma shipments: Deviations handling case studies (13 pages)

• Deviation report case studies: Road transport shipment
• Deviation report case studies: Ocean transport shipment
• Deviation report case studies: Airfreight shipment