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white bpf Aseptic processes - Performance Qualification:
Simulation / Media Fill Test (APS / MFT)

 
BPF12      
PUBLIC
- Pharmaceutical industry and associated industries
- Technician and manager responsible aseptic operations
- Operator
- Assurance qualité

OBJECTIFS
• From sterilizing filtration to the final product: how to establish a robust, effective qualification program that meets international regulatory requirements.

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 and practical exercises

 

PROGRAM   NOTE MOYENNE
17given by previous interns

DUREE
2 days


PROCHAINE SESSION
4 and 5 2018 April

FORMATEUR
Dominique SIERAKOWSKI


TARIF
1 200 € HT
(Lunch included)


PICTO telechargerPDF 01
inscriptionbpf

The first day devoted to the simulation of aseptic processes shows the importance of this regulatory requirement both in the final aseptic production phases and also in the preparation of sterile active substances.
Good practices and frequently encountered errors, special cases of barrier technologies are studied.

The second day on sterilizing filtration deals with regulatory aspects, validation of retention
microbial and integrity tests.

Introduction and prerequisites

• Update on EU, FDA, CFDA, WHO, etc. standards. guidelines their interpretation and current practices encountered in the industry.
• Demonstrate the value of risk analysis in defining the key elements to an aseptic process simulation program (initial and periodic).
Practical example of a risk analysis to identify the "worst case" situations and critical points of the operations to be qualified.

Case studies :

• In conventional environment / RABS and isolators
• For liquid and freeze-dried preparations
• Vigilance points for each application

The documentation :

• How to prepare for the presentation of the MFT during an inspection
• Integrity tests: process vessels, filling sets and sterilizing filtration.

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
experts to offer you professionals quality
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2018 training program

 

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