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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.

 

PROGRAM   NOTE MOYENNE18 3given by previous interns

DUREE
1 day


NEW DATE
November 23 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
pierredevauxExpert Control of Contamination
An expert in contamination control, he performs audit, consulting and training missions for the Healthcare Industries around UPS Consultants around the following themes: validation of cleaning, cleaning of premises, good Aseptic practices, implementation Place of risk analysis to control the contamination of manufacturing processes, GMPs audits and investigation on problems of contamination of products.

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 - Contamination control in ZAC (sterile and non sterile)
BPF10Understand and implement the requirements of the new Annex 1 of the European GMPs

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