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white process Production campaign work with insulators

PROC07      

PUBLIC
- Quality Assistant
- Microbiology Laboratory Manager
- Responsible qualification / validation
- Quality manager
- Production manager
- Production Director
- Responsible Supply Chain
- Production Maintenance Manager
- Responsible engineering project

OBJECTIFS
• Analyse constraints that limit the size of the filling campaigns under isolator.
• Assess optimization opportunities to extend the duration of these campaigns.
• Identify areas for improvement of the microbiological quality within the isolator.
• Improve productivity by using the best insulators production.

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.
Case studies.

 

PROGRAM


DUREE
1 day




DATE
2018



FORMATEUR
Julien TRIQUET - GSK


TARIF
800 € HT
(Déjeuner inclus)
 



PICTO telechargerPDF 01


inscriptionprocess
The size batches campaign products in conventional aseptic atmosphere has always been limited by the risk of contamination. The introduction of the isolator technology has decreased very significantly contamination related to operators and facilities.
Some manufacturers now equipped with insulators, have not so far questioned the campaign size production.
Some others, however, managed to extend their sterilization frequency isolators 3 months to succeed by making products of different therapeutic classes without or microbiological cross contamination.

Exchanges with participants around the constraints that govern the operation in filling campaign insulators, namely:
• Batch startup procedures
• The analysis of microbiological monitoring and critical events
• Control of gloves & Wristbands
• Withdrawals
• Cleaning procedures
• The decontamination cycles
• The calibration & maintenance schedule
• The organization of personal work Production, Quality and Maintenance
• The nature of products filled in the insulator
• Batch size and campaigns
• Scheduling
• Performance TRS equipment ...

Definition of the limiting factors of labor campaign under isolator

Case Studies are utilized to identify potential sizes campaign optimization opportunities and the improvement in terms of track quality, scheduling, production capacity, work organization of different personal ... 

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

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