Temperature Controlled

Latest Regulatory Guidelines on Cold Storage & Temperature Mapping

Course Objectives:

This one day training course aims to offer participants an understanding of temperature control and monitoring issues that are involved in the transport and storage of pharmaceutical products.

To give companies an understanding of the new temperature mapping requirements that the Irish Medicines Board (IMB), MHRA and EU regulators now like to see when reviewing licence holders either at GDP or at GMP level.

To give details about temperature mapping and ‘hot & cold’ points and how these are used for ongoing temperature monitoring.

Dates: Available on request – please contact us.

Why is this training important?

Storage is a critical parameter in maintaining the quality, safety and efficacy of a medicinal product. Product must be stored in accordance with the requirements of its market authorisation.

Legal Obligations

EU Directive and Regulations
Medicinal Products (Wholesale Licences) Regulations at EU Level
EU Guidelines (including New EU Consultative Guide 2011) on Good Distribution Practice

Target Audience

Warehouse and distribution staff and management
Transportation staff
Quality Assurance staff and management
Materials/Supply Chain department staff and management
Purchasing, planning, inventory management staff
Logistics and customer services personnel
Air and Sea Cargo Handling & Storage staff and
management

Target Sector
Logistics and warehousing companies
Transport Companies
Companies supplying to the pharmaceutical and medical devices sectors
Pharmaceutical and Medical Device Manufacturers

Course Details:

For further information or to book a place please contact us.