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white process Quality by Design for biotech

 

PROC12      

PUBLIC
From Senior Technician to Global Process Development Manager

PRE REQUIRED
Understand and have practiced process development, technology and process transfer and / or production of biotechnology products.

OBJECTIFS
• Understand what QbD actually means and in practice and be able to implement it in existing or future projects.
Understand how to integrate QbD into project schedules.

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.

 

PROGRAM   new

DUREE
1 day


PROCHAINE SESSION
2018


FORMATEUR
Alain BERNARD


TARIF
800 € HT
(Déjeuner inclus)


doc5
inscriptionprocess
As part of a QbD approach, the design and development of processes and products performed by a pharma company must be based on what the product's performance objectives and critical quality attributes will be. determine the safety and efficacy of the product when administered to humans.
This training will describe the various contents of the QbD approach and how best to integrate it into development projects
QbD establishes the basis for understanding the impact of raw materials and process parameters on product quality. The approach also aims to study the source the impact of the variability of these parameters on the qualities of the product.
The training will allow to acquire a methodology to implement the QbD approach for biotech and / or chemical synthesis processes and products.
It is therefore a matter of "demystifying" the QbD. The costs associated with QbD can be mitigated and offset by quality regulatory submissions. These bids will have a higher chance of being approved.
QbD is not just a regulatory requirement, but must lead to reliable and robust production.
During the course of the course several real case studies will illustrate the key aspects of the QbD approach for biopharmaceuticals.

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

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2018 training program

 

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