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Tools and Practices

SI04      

PUBLIC
- Assurance qualité
- IT

PRE-REQUIS
Basic knowledge of the supplier audit

OBJECTIFS
• Know when and how to audit a supplier of products / IT services.
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.
Études de cas

 

PROGRAMME DUREE
1 day

DATE
29 2017 June

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


TARIF
800 € HT
(Déjeuner inclus)


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inscriptionsi

The most recent regulations highlight the crucial role of IT products and services provider in regulatory compliance of regulated systems and the need for their prior assessment and continuous. Given the complexity of the current IT landscape (infrastructure outsourcing, SaaS software provided ...), how to better assess and cost the suppliers whose quality standards are often away from our regulations?
The training offer from concrete examples and case studies of effective and efficient methodology to rapidly assess the skills of an IT / IS provider.

Why evaluate SI / SA providers?
regulatory, project context

How to evaluate?
• Standardized approaches: ISO 19011, GAMP, ...
• Major IT standards
• Planning / internal management assessments

Case study :
• Evaluation of a mode software provider SAAS
• Criticality Assessment and the need for an audit
• Calendar and audit plan

Debriefing and evaluation of training

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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