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white bpf Appropriate QRM to control patient risk - ICH Q9

- Anyone involved in patient risk management activities: development, project management, industrial transposition ...

- Collaborator of functions: quality, Process owner,
Production, support services, engineering of manufacturing establishments and operators
• Understand the stakes and the interest of setting up the QRM to drive and optimize decisions within the company
Appropriate the QRM fundamentals, the ICH Q9 process, the vocabulary
Appropriate the keys to success of a QRM implementation based on a Product / Process / Process approach
Establish effective organizational arrangements for the implementation of the QRM up to the Risk Register.

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



800 € HT
(Déjeuner inclus)

PICTO telechargerPDF 01


The Pharmaceutical Context - Regulatory Requirements QRM
O The positioning of the QRM in the regulations
O The concepts of ICH Q9

Quality Risk Management in practice
O Fundamentals of ICH Q9
O Transposing operational translation of ICH Q9
O The analytical level approach (Process - Product / Process)
O Key points of the approach
O Key success factors for operational implementation
O Tools

Deployment of the QRM and its piloting on a daily basis
O The organization to be set up, the skills required
O Facilitating patient risk analysis exercises
O The deployment approach
O Operational management of patient risk management

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
consultant Trainer

An industrial chemist graduated from the Faculty of Pharmacy in Lyon and an engineer in chemical and biopharmaceutical engineering from the Ecole Polytechnique de Montréal, she spent 5 years in production (liquid forms distributed in aseptic and solid forms) in the Opodex and Cenexi laboratories . She joined Aktehom 9 years ago (2008) to work as a consultant.

As an expert consultant, she assists clients in the control of their quality systems and processes: from industrialization to validation, but also its partner clients in the deployment of a Quality Risk Management and Quality by Design Products and processes in development or in operation.

A3P training:
BPF08 - Appropriate QRM to control patient risk - ICH Q9

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