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white bpf Process of accreditation and monitoring of excipients manufacturers
Directive of March 19 2015 (2015 / C95 / 02)

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PUBLIC
- Any person involved in the accreditation process and monitoring quality of excipients manufacturers
OBJECTIFS
• 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.

MOYENS PEDAGOGIQUES
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.

Case studies, practical exercises and work in small groups

 

PROGRAM  




DUREE

1 day




DATE

2018


FORMATEUR
Olivier JEAN



TARIF

800 € HT
(Déjeuner inclus)


PICTO telechargerPDF 01

inscriptionbpf

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.

Morning

FIRST PART : Presentation of the directive and analysis tools
- Presentation of the Directive
- Presentation
- Discussions and exchanges

Presentation of tools and methods to address them
- Definition of the risk profile of the excipients (MCA)
- Definition of the required GMP (Table)
- Definition of the manufacturer's risk profile (MCA)
- Crossing of two risk profiles (approval process)
- Monitoring quality manufacturer of excipients (demerit)
- Expression of expectations (CoC quality and schedule)

Balance sheet
- Self evaluation
- Reflection on strengths and your business progress points
- Drafting of an action plan

Afternoon

SECOND PART : Practical Applications

Work in teams
- Formation of teams and distribution of exercises:
• Definition of profiles
• Definition of GMP
• Definition of needs
• Quality report
- Reflection in sub-groups- exercises
- Collective Restitution (subgroup)
- Balance sheet - Drafting a plan of action

Working matrix presentation

Expression of GMP requirements
Saving GAP

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.
No Declaration: 82 69 13448 69 Pref. Region Auvergne Rhône-Alpes
SARL au capital de 10 000 Euros Siret 451 934 541 00025

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