Customised In-house Courses are designed for organisations wishing to train a group of your employees at a location of your choice.
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
New EU Guideline on IMPs and Non-IMPs
Requirements for Manufacturing
- What constitutes manufacturing
- Role of QP
- Licenses required
Site Management of IMP
- Personnel
- Premises
- Equipment
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