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white process Comparability of biotech, innovative and biosimilar products

 

PROC15      

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 the production ..

OBJECTIFS
• Be able to design and conduct comparability studies at key project points with appropriate scope and cost control.
Use comparability to establish the red thread of the product during its development.
Acquisition of a personal and concrete experience by each participant for the design of comparability studies.

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)


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inscriptionprocess

What is comparability? Why is this key? When and how to study the comparability of products. Comparability is often misunderstood and is not implemented at the right time.

This training will allow each participant to avoid the most common mistakes and errors ...
The comparability of products and processes makes it possible to establish the "red thread" for the development of processes and products over the entire product life cycle until commercialization. This training will describe what comparability is, why it is essential to implement it as early as possible in the course of technical development and how to implement it.

Through the use of case studies, participants will develop comparability strategies and their implementation plan.
The training will also address the costs, durations and limitations of comparability.
The proposed approaches will be applicable to both innovative products and biosimilars.

MORNING

What is comparability in which cases is it applicable and useful and how to manage it

Why follow comparability, what are the benefits?

What happens when comparability is not judiciously implemented

Tools and methodologies for managing comparability

Case studies: designing a comparability studys

AFTERNOON

Case Studies: Designing a Comparability Study (cont'd)

Case Studies: Develop a comparability study program (over the life cycle of the product and processes)

Share findings from school cases

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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