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Contamination control by ZAC
(Sterile and non sterile)

MC08      
PUBLIC
- Manager of the production and maintenance teams
- Operator of production and maintenance
- Microbiology Lab technician performing the
environmental controls in clean rooms
- Technician of the utilities involved in proprese rooms
OBJECTIFS
• Mastering the application of GMP's for the manufacture of sterile products in clean rooms (Class D to the class A / B).
• Know the major repositories applicable to your activities and the operation of a BIA.
• Apply Best Practices Aseptic based on situations encountered in cleanrooms.
• Understand the positive results of particulate and microbiological controls performed at your premises.
• Being able to help Quality Assurance in operational investigations due to contamination problems.
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.

 

PROGRAMME  

NOTE MOYENNE
17 7given by previous interns


DUREE
2 days


PROCHAINE SESSION
27 and 28 2017 June


FORMATEUR

Pierre Devaux
Head Pharmacist
Expert in contamination control



TARIF

1 200 € HT
(Lunch included)


PICTO telechargerPDF 01


inscriptionmc

regulatory point with a focus onfollowing standards:
Appendix 1 subject to interpretation and therefore PIC'SPI032-2, 2004 GFI Aseptic Process, PDA TR62 and USP<1116>

The various contaminants and contaminationcross:
Particles, microorganisms, chemicalsand static electricity

1 - The contamination process
• a clean room operation Other industries are also affected and the fragility of the different
barriers including the quality of the air filtration and maintaining the overpressure (see depression in some cases) should be known
• Special case of aseptic repair with a focus on the different configurations: A classic in B division, use of RABS and use of isotechnie

2 - The classification and monitoring facilitiesown
The various tests to classify your premises including the smoke tests, return to the "specifications described in Appendix 1" and the new version of 1116 USP, explaining the different sampling methods (operation of a particle counter ,

Air sampling using aero Biotest Air Sampler by impaction, by collection of gelatin and transfer, on the latest developments in the field, sampling of surfaces by swab, contact agar .... exposed boxes, controls gloves) and interpretation of the results transmitted.

3 - The flow of staff and materials
• Operation of various SAS: equipment, personnel and supplies
• Clothing used in clean rooms
• Personal hygiene: hand washing and dressing procedures based classes

4 - Great principles on behavior and body language to be adopted for Good Practices Aseptic
- In class C and D
- In class A / B and B

Focus on Media Fill Tests

The main principles of bio-cleaning in clean rooms


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
Pierre Devaux
pierredevauxHead Pharmacist
Pharmacist responsible and quality director at ACM Pharma, he is a consultant for training, audits and advice on pharmaceutical and cosmetic production sites.

Training A3P:
MC02 - Validation of production equipment cleaning processes in pharmaceutical industry
MC07 - Development of a bio-cleaning program in cleanrooms in GMP environment
MC08 - Control of contamination by ZAC (sterile and non-sterile)

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