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


Technician and framework of quality assurance, production, environmental controls
• 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.

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.




1 day


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

PICTO telechargerPDF 01
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:
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

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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