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white stopmicrobe Analyse du risque sur les étapes critiques de procédés stériles, aseptiques ou à contamination contrôlée

 

MC09      
PUBLIC
- Process Development Manager (articles, process steps)
- QA Manager in operational quality and quality suppliers
- Regulatory Compliance Manager and updating of regulatory files
- Engineering equipment Head
- Responsible for qualification and validation
- Microbiology laboratory manager
OBJECTIFS
• Have a method and rational way to deal confidently wherever sterility assurance is not of the same features or specifications and avoid the "over-quality" associated validations.
• Differentiate the stages of production and other risk controls without minimizing the risk "patient" or the risk of regulatory non-compliance. The microbiological status just right effort in risk assessment, implementation of the qualification / validation for reasoned monitoring.
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.
Studio work and in groups.

 

PROGRAM  

NOTE MOYENNE
17 4given by previous interns


DUREE
2 days


PROCHAINE SESSION
17 and 18 2018 April


FORMATEUR

Alain EUZEN
Expert quality systems
Auditor



TARIF

1 200 € HT
(Lunch included)


PICTO telechargerPDF 01


inscriptionmc

The analysis of microbiological risk is borne by each company's requirement levels for a given process and a product which determines the expected level of sterility assurance. Using the same tools, but starting from the final specification, then each process step and each intermediate product are subject to specification in microbiological contamination (or bioburden) variables whose values ​​condition upstream and downstream means of prevention or suitable detection. That is why there is no single answer to this question, which demonstrate the trainer inputs - expert and participants during the session.

1 DAY

The sterility assurance principles in terms of official documents and product specifications (sterile, injectable and controlled contamination)

Reminders of sterilization and decontamination methods and their effects

Studies and / or description of sterile processes, aseptic, controlled-contamination: steps, sub - steps, analysis of failure modes and / or rapid analysis of potential defects

Highlighting the critical parameters of control and critical quality attributes for the selected state and necessary bioburden

2 DAY

Work in teams and subgroups to define the parameters prevention, detection and associated methods and processes

Pooling

Review of a general pattern compatible with different requirements and sound made during the validation processs

Conclusion

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 EUZEN
alaineuzenExpert quality systems and Auditor 38 years of management experience and business activities as Director of profit center operations manager, quality manager and responsible for technical and regulatory affairs, head of industrial projects and is responsible for customer development France, Europe and abroad is a professional recognized for its global approach, its managerial, technical and actions to improve skills in health and related industries.
He is expert in quality systems applied to medicines, medical devices and care cosmetics as well as hospitals.


Training A3P:
MC09 - Risk analysis on critical stages of sterile processes, aseptic or controlled contamination
MC10 - Particulate risk analysis in sterile injectable products

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