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

 

MC13      
PUBLIC
Technician and Quality Assurance, qualification and validation services, environmental controls
OBJECTIFS
• Know and understand the provisions of the new version of the ISO 14644-1 standard.
• Ability to update internal classification procedures.


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.

 

PROGRAM

NOTE MOYENNE
17 2given 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 evolutions of the new version of the ISO 14644-1 standard. After a reminder of the elements that led to the modification of this standard, the trainer will present the evolutions of this new version, particularly in terms of sampling plans.

The trainees will then be able to work on a concrete case of drawing up a sampling plan in conformity with the new version of this standard. If they wish, the trainees will be able to agree on a telephone appointment of 2h00 after the training, to discuss possible difficulties encountered during the implementation of the notions acquired during the training.

MORNING

. Reminder of the justification for the new version of the standard
. The provisions of the new standard
. The principle of the hypergeometric law
. The sampling plan

 

AFTERNOON

. The rules for concluding class compliance
. Comparative study of the 1999 and 2015 versions of the standard
. Application to the construction of zone sampling plans according to the new version of the standard
. Exchanges on the particular situations proposed by the participants

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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