Description:
This online module will provide an understanding of Good Manufacturing Practice requirements for Investigational Medicinal Products and practical guidelines for ensuring GMP is followed at site
Who it is suitable for:
The course is aimed at anyone involved in the supply and management of IMP for investigational sites, e.g. CRA/Monitor responsible for monitoring investigator sites. The course is specifically relevant for
 CTAs
CRAs
Project Managers
Pharmacists
Investigators
Course Contents
Introduction to GMP
Annexe 13 of Eudralex Vol 4
Quality Management
Documentation
Production
Relabeling
QC
Batch Release
QP Release Exemption
Shipping
Storage, Dispensing and Accountability
Return and Destruction
Responsibilities: Sponsor, Investigator and QP
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