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white process Risk assessment in the pharmaceutical and biotech industry

 

PROC13      

PUBLIC
Senior Technician, Unit and Group Leader, Manager, Manager
Anyone involved in CMC development, production, continuous improvement, quality control, quality assurance of biopharma products

PRE REQUIRED
At least 3 years in the pharmaceutical industry in a role related to the technical development of products and processes and / or in production.

OBJECTIFS
• Understand my risk management approach to biotech processes and products.
Be able to build, maintain and manage a complete portfolio of risks.

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.

Practical exercises to create a risk portfolio project de-novo
Practical Exercises to Develop a Risk Management Culture

 

PROGRAM   new

DUREE
1 day


PROCHAINE SESSION
2018


FORMATEUR
Alain BERNARD


TARIF
800 € HT
(Déjeuner inclus)


doc5
inscriptionprocess
Risk management: from theory to practice
In the pharma and biotech industry, risk management helps to anticipate unforeseen events that may affect the quality, safety and efficiency of products and production processes. Regulatory authorities recommend that risk management be an integral part of pharmaceutical companies' quality systems and use both formal and informal approaches (see ICHQ-8-9-10).
The aim of this training course is to quickly review the various regulatory guidelines, definitions and methods. Then the key principles will be applied to case studies and the participants will be put into real risk management situation in small working groups.
These exercises will replicate various business scenarios and the groups will have to propose a rational strategy of risk management as well as a plan of execution of this strategy.
The final part of the training will be devoted to sharing the findings of the different groups and a brief SWOT analysis of the proposed solutions.

MORNING

Risk Management Review

Why is risk management essential?

Regulatory guidance

Risk management methodologies

Exercise in mini-workshops

AFTERNOON

Share and analyze the conclusions of the mini-workshops

Risk management at different organizational levels of a company

Change of culture towards risk management in a group, department, division, company

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

A3P TRAINING 2018

Knowledge enhancement and its mastery

Throughout the year, A3P brings together
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2018 training program

 

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