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white stopmicrobe  The new version of ISO 14644-1:
What changes?

 

MC06      
PUBLIC
- Management of production services
- Maintenance
- Assurance qualité
- Qualification / validation
OBJECTIFS
• Know and understand the provisions of the new version of ISO 14644-1.

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 study and implementation.

 

PROGRAMME

NOTE MOYENNE
17given by previous interns


 DUREE
1 day


DATE
2018

FORMATEUR
Philippe DUHEM
responsible validation
Expert GMP and clean and sterile processes
TARIF
800 € HT
(Déjeuner inclus)

PICTO telechargerPDF 01
inscriptionmc
The objective of this training is to know and understand the changes in the new version of ISO 14644-1.
After recalling the elements that led to modify this standard, the trainer will present the evolution of this new version, particularly in terms of sampling plans.
Students can then work on a concrete case of developing a sampling plan in accordance with the new version of this standard.

MORNING

Reminder evidence justifying the new version of the standard "Cleanrooms and associated controlled environments"
• The provisions of the new standard
• The principle of hypergeometric
• The withdrawal plan
The conclusion of rules for compliance with the class

 

AFTERNOON

Application: building the withdrawal plan of an area according to the new version of the standard.

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

Philippe DUHEM
philippeduhemValidation manager
Expert GMP and clean and sterile processes
Biochemist and biologist by training, he worked 10 years in the pharmaceutical industry as production manager before joining the Intertek Group, where he is senior consultant. Expert GMP and clean and sterile processes, it is particularly involved in the healthcare industry where it provides validation missions, consulting, auditing and training. Expert in international standardization committee in charge of ISO 14644-1 and 14644-2, it also ensures regular training to inspectors certain health product regulators.

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