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white bpf Integrate the concepts of QBD - ICHQ8, Q9, Q10 and Q11

- Any person involved in development, industrialization, industrial exploitation, quality assurance, regulatory or pharmaceutical affairs.

- Collaborator of the functions: quality, qualification / validation, industrialization, production and engineering of establishments manufacturers and operators.

• Appropriate concepts introduced by the ICH guidelines Q8, Q9, Q10, Q11
Understand the interactions and synergies determined by these guidelines
Understanding the Fundamentals of Pragmatic Implementation

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.




1 day

30 November

Delphine BERNOUD


800 € HT
(Déjeuner inclus)

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Context of the ICH guidelines: Quality by Design and Critical Path

The concepts ICH Q8 and Q11
O Characterization Product: Critical Quality Attribute
O Process characterization: Critical Process Parameter and Material Attribute
O Control Strategy
O Development according to a quality mark

ICH concepts Q9: Risk management process focused on patient risk:
O Fundamentals
O The integration of risk management in the implementation of a QbD approach

The concepts ICH Q10: Pharmaceutical quality reference system
O Exploiting the QbD approach

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
Delphine BERNOUD
consultant Trainer

Industrial Pharmacian, graduated from IPIL, she has 4 years of experience in industrialization of dry forms in the Biogaran laboratory. She is an expert consultant with Aktehom and head of the Lyonnaise team since 2006. In this capacity, she works with clients in the pharmaceutical sector to master the product / process pair: from industrialization to validation.

It participates actively in the understanding, interpretation and operational implementation of the Quality by Design approach to its partner customers on products and processes in the development, transfer or operation phases.

A3P training:
BPF09  - Integrate the concepts of QbD ICHQ8, Q9, Q10 and Q11

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