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- Pharmaceutical industry and associated industries producing organic products
- Biotechnology: production, quality control, quality assurance, technical departments, logistics and regulatory affairs
• Understand the new regulatory requirements for organic products in GMP and BPD for the EU and the WHO.
• Review and understand the latest regulations and the recent proposals of Good Manufacturing Practices for Innovative Therapy Drugs (MTI) or Advanced Therapy Medicinal Products (ATMP).
• Develop and validate the conditions of storage and distribution for biological products sensitive to temperature.

En début de session, grâce à un questionnaire, le formateur analyse le niveau de connaissances des professionnels sur le sujet ainsi que leurs attentes des connaissances à acquérir.
Le formateur adapte le programme de la formation en fonction du profil des différents participants. Un temps est consacré aux échanges d’expériences entre participants et avec le formateur.
Pour un bon suivi du stage, le stagiaire dispose d’un ou plusieurs supports de cours en version numérique et en version papier.


15 5given by previous interns

1 day

session Cancelled

trainer consultant 

800 € HT
(Déjeuner inclus)

PICTO telechargerPDF 01

This training is based on the presentation, understanding and applying the latest GMP requirements and BPD applicable to biological and biotechnological products. It includes a review of Annex 2 2014 and 2014 BPDG and those of WHO for BPD and temperature sensitive products. The specifics of therapy products are reviewed and discussed in relation to their specific GMP regulations.
EU Annex 2 2012
• Background: EU law, why a new Annex 2, scope
• Presentation: common part, specific part to the different categories of organic productsand biotechnology
• Conclusion: key developments and possible future changes

Innovative therapy drugs
• Background: binding regulation and its likely developments in GMP / GMP
• Presentation: the different types of MTI and MTI Prepared Selectively (MTI-PP), hospital exemption, changes and challenges

Good Distribution Practices
• Regulatory requirements 2013 EU GDP and GDP WHO TRS Annex 957 5 2010 and TRS, 961 Annex 6 2011 TTSPP
• Main and new requirements of EU GDP / BPDG
• Specifics of the WHO requirements for biological products thermosensitive

Évaluation des connaissances acquises et évaluation des actions d’améliorations entreprises et/ou envisagées

Questionnaire de satisfaction

Cette journée s’inscrit dans le cadre de la formation professionnelle.
N° Déclaration : 82 69 13448 69 Préf. Région Rhône-Alpes
SARL au capital de 10 000 Euros Siret 451 934 541 00025

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