|GMP and GDP of biological products and advanced therapy medicinal products||
- 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.
given by previous interns
|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
Good Distribution Practices
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