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

The distribution of pharmaceutical products remains challenging with the changing regulatory requirements and with the increasing demand for efficiency and compliance. Thus, everybody involved in pharmaceutical storage, transportation, cold chain and distribution activities needs to know at least the basics of GDP.

During the Live Online Training "GDP for Beginners" on 02/03 March 2022, 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 newly developed pre-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 system for pharmaceutical products

Best Practices in Transport and Logistics (21 pages)

• Quality and Service Level Agreements
• Active and Passive shipping systems and transport equipment
• Change control for transport processes

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