PharmaSchool: GMP for Clinical Operations

Please contact Jo Burmester at jo.burmester@pharmaschool.co.uk to find out more about in-house courses and discuss your specific needs.

Course Code: GGL006

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Duration: 1 day

Description:

This course aims to provide delegates with an understanding of GMP requirements for IMP 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. For example, CTAs, CRAs, Project Managers, Pharmacists, Investigators.

Example Content:

Background

Documents
Regulatory and Advisory Bodies
Definitions

Annexe 13

Content
Implications

New EU Guideline on IMPs and Non-IMPs

Content
Implications

Requirements for Manufacturing

What constitutes manufacturing
Role of QP
Licenses required

Site Management of IMP

Personnel
Premises
Equipment

Customised In-house Courses are designed for organisations wishing
to train a group of your employees at a location of your choice.
For information about Open Courses click here or for
online learning click here

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