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white process Process Validation and Technology Transfer

PROC11      

PUBLIC
Beginner and professional with a few years experience in the pharmaceutical industry, working in quality assurance, scientific support, production, projects.

OBJECTIFS
• Understand the regulatory requirements in relation to process validation and how to implement them in order to achieve a controlled industrial process.

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.
After the course, participants will receive paper and digital copies of the course's content.

 

PROGRAMME  

new


DUREE
1 day


DATE
 

TRAINERS
Alain NONN
consultant Trainer

Catherine MICHAELI
consultant Trainer


TARIF
800 € HT
(Lunch included)


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inscriptionprocess


Understand the regulatory requirements with regard to process validation and how to implement them in order to obtain a controlled industrial process.




Day 1 - Morning:

Introduction to regulatory requirements, overview of process validation, pharmaceutical development

Day 1 - Afternoon:

Transfer of technology, Qualification of process performance, continuous monitoring

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
Alain NONN
consultant Trainer

Alain Nonn is a chemical engineer and PhD in chemistry from the University of Strasbourg. After five years in the chemical industry as a researcher and production support, he joined Lilly in France 1990. He held various positions in management and expertise within the Scientific Direction. He participated in many technology transfer projects and process validation. In his current position, he is responsible for overall scientific two drugs, scientific consultant on technology transfer projects and head of scientific development.

A3P training:
PROC11- Process Validation and Technology Transfer

 

Catherine MICHAELI
consultant Trainer

Catherine Michaeli is a doctor of pharmacy degree from the University of Strasbourg. She joined Lilly in France 1995. After 6 years in the Department of Regulatory Affairs within the Quality Department, she joined the Research Office. In process validation load during 3 years, she then coordinated many projects: change of active material, batch size increase technology transfer. She is currently the Project Consultant position.

A3P training:
PROC11- Process Validation and Technology Transfer

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