|Process of accreditation and monitoring of excipients manufacturers
Directive of March 19 2015 (2015 / C95 / 02)
- Any person involved in the accreditation process and monitoring quality of excipients manufacturers
• Know the main expectations and requirements of the European Directive of March 19 2015.
•Know and apply the necessary analysis tools to define the risk profile of your excipients.
•Consider appropriate GMP according to the risk profile of your excipients.
•Namely to determine the risk profile of your manufacturers.
•Namely to monitor quality of its excipients manufacturers and confirm the application of GMP.
Case studies, practical exercises and work in small groups
1er June 2017
|This course will introduce the main expectations and requirements of the European Directive of March 19 2015 and will apply the necessary analysis tools to define the risk profile of the excipients.
It also will determine the risk profile of the manufacturers of these excipients and adapting the monitoring quality of these suppliers.
FIRST PART : Presentation of the directive and analysis tools
Presentation of tools and methods to address them
SECOND PART : Practical Applications
Work in teams
Working matrix presentation
Expression of GMP requirements
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