Good Manufacturing Practice (GMP) in relation to GCP

Course Content
This one day course is designed for professionals who are involved in the handling of investigational medicinal products. They will get an overview of the latest regulatory standards set by the European Union including Directive 2001/20/EC, 2003/94/EC, 2005/28/EC, Annex 13 of EC-GMP Guideline, ICH GMP Q7 and ICH GCP E6 guidelines.

Learning objectives, training objectives
To give a comprehensive overview of the different regulatory references regulating GMP requirements for investigational medicinal products.
To explain steps, roles and responsibilities in the course of IMP manufacturing and processing.

Target Audience
Monitors, project managers, site personnel, or administrative persons who are responsible for sending, storing, accountability, final disposition, etc of medicinal products used in clinical trials.

Certifications
ISO 9001:2008/ Q-for

Ms. Sunita Kelecom