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white stopmicrobe Development of a bio-cleaning program in cleanrooms in GMP environment

 

MC07      
PUBLIC
Under production services and quality services concerned with cleaning and disinfection of surfaces and general control of contamination in clean rooms for pharmaceutical use
OBJECTIFS
• Learning about GMP context of cleaning the premises.
• Master the choice of methods to establish and adapt to GMP requirements.
• Develop a bio-cleaning program adapted to local and activity.
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 MOYENNE3312812908given by previous interns

DUREE
1 day


NEW DATE
12 October 2017


FORMATEUR
Pierre Devaux
Head Pharmacist
Expert in contamination control


TARIF
800 € HT
(Déjeuner inclus)


PICTO telechargerPDF 01


inscriptionmc

The GMP context of control of contamination and cross-contamination

Means of struggle against contamination
preventive and curative aspects; cleaning, first pharmaceutical activity, etc.

Cleaning cleanroom technology (equipment, product, method)
• Dusting
- Aspiration
- Wiping / wet sweeping

• Washing
- Washing of surfaces related to general workplace
- Settings optimizing cleaning methods

• Disinfection
- By spraying, by contact, by air

• Methodology of bio-cleaning
- During the activity, later in the day, at the end of the lot, at the end of campaign, etc.
- As part of a clear-up

• The documentary aspect
- Schedules, processes and procedures; key points
- Monitoring documents
- The audit working papers
- Presentation and demonstration of different materials and consumables available on the market(wipes, brooms, ...)

The means of controls and audits

Summary and Discussion

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
Quality Manager 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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