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white stopmicrobe  The new version of ISO 14644-2:
What changes?

 

MC14      
PUBLIC
Technician and framework of quality assurance, production, environmental controls
OBJECTIFS
• Know and understand the objectives and provisions of the new version of ISO 14 644-2.
• Know and understand the issues to consider when developing a monitoring plan.
• Know and understand the elements to consider when setting monitoring limits.


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

new


 DUREE
1 day


DATE
April 26 2018

FORMATEUR
Philippe DUHEM


TARIF
800 € HT
(Déjeuner inclus)

PICTO telechargerPDF 01
inscriptionmc
This training session gives trainees the opportunity to participate in a telephone training follow-up appointment.
This follow-up may enable them to discuss with the trainer any difficulties encountered in applying the concepts studied during the training and / or to ask additional questions.

1. Reminders of the objectives of this standard

1. Differences in approaches between classification logic (ISO 14 644-1) and monitoring logic (ISO 14 644-2)

2. Positioning of surveillance in a GMP-type operating context:
Qualification
Classification
surveillance
Maintain status Qualified

2. Review of the overall strategy for the implementation of a monitoring plan

1. General principles
2. General Implementation Strategy

3. Expected elements for the monitoring plan

4. Considerations for developing the monitoring plan

1. The risk analysis
2. The definition of the operational conditions to be monitored
3. The choice of the parameters to be monitored, and the conditions of this monitoring

5. Considerations for establishing monitoring limits

1. Determination of normal operating ranges
2. Determination of alert and action limits
3. Determination of the conduct to be taken in the event of exit from the surveillance limits

  

 

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

A3P TRAINING 2018

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