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- Assurance qualité
- Service validation and IT
• To understand the concept of "cloud computing" and its various features.
• Understand pharmaceutical regulations (GxP) and constraints on computerized systems in "cloud" mode.
• Assess regulatory risks of the various proposals "cloud" (IAAS, PAAS, SAAS) with examples.
• Derive strategies qualification / validation and control of associated risk.

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.
Studies of methods and standards.
Case studies


16 8given by previous interns 

1 day

7 September 2017

Jean-Louis Jouve
Consultant pour l’industrie Pharma & Biotech

800 € HT
(Déjeuner inclus)

PICTO telechargerPDF 01
"Cloud computing" is playing an increasingly important role in the IT landscape of the health sector through outsourcing of IT resources and use "on demand" software for regulated. With some benefits (scalability, cost control ...), the "cloud computing" also has particular constraints related to its use in a regulated environment.
This training is intended, from case studies based industrial experiences, take stock of the different modes of "cloud computing", to know their weak points vis-à-vis the applicable regulations and infer a plan to control adapted risks.

Reminders and definitions
• The "cloud computing":
Definitions and technology, the different offers: IAAS, PAAS, SAAS, advantages and disadvantages

• The regulation of Computerized Systems (EU and FDA):
general and specific principles to the "Cloud" (concept of electronic registration, open / closed system
responsibilities, subcontracting, etc.)


Études de cas
• Infrastructure as a Service (IAAS)
It proposes to modernize and outsource your IT infrastructure with a service that offers a virtualized architecture type "cloud":
- What are the risks associated with such a project?
- How to approach the qualification / validation?

• Software as a Service (SAAS)
A publisher offers to use SaaS application hosted by him:
- How to approach this project?
- What are the risks? What audit?
- From qualification / validation?

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
Jean-Louis Jouve
Jean Louisconsultant Trainer graduate engineer ESCIL and the University Lyon 1 in Analytical Chemistry (DEA), it is, since November 2004, manager and principal consultant Coetic, expertise and consulting firm dedicated to regulated industries (pharmaceutical, biotech, principles active pharmaceutical and medical devices).
In parallel, he has been involved in several projects of regulatory compliance of computerized and automated systems. He is also responsible ICG A3P eCompliance (Electronic Compliance) and serves on the board of A3P.
As an expert, he was invited as a speaker at several international conferences and seminars and is the author of several articles and scientific publications.

Training A3P:
SI01 - Cloud computing and drug regulation
SI02 - Audit and inspection of computerized systems: tools and methods
SI03 - Validation of effective and efficient information systems
SI04 - Evaluation of IT / IS suppliers Tools and Practices
SI05 - Audit and solving the problems of "data integrity" to the quality control laboratory

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