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white systemesinfo Audit and inspection Computerized Systems:
Outils et méthodes

SI02      
PUBLIC
- Assurance qualité
- IT
- Business
OBJECTIFS
• Understand the critical points of computerized systems.
• Be prepared to respond in case of inspection.
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 des différentes méthodes et référentiels

 

PROGRAM   NOTE MOYENNE
15 4
given by previous interns
DUREE
1 day

PROCHAINE SESSION
19 October 2017

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


TARIF
800 € HT
(Déjeuner inclus)


PICTO telechargerPDF 01


inscriptionsi
The evaluation of computer systems can be performed by multiple repositories and audit grids.
Is there a reusable global repository?
What are the expectations and practices of French and American inspectors?
How to effectively prepare for an inspection?
La formation se chargera de répondre à ces questions à partir d’exemples et d’exercices réalisés en commun.
Introduction
Audit & Inspection similarities and differences

1 - The audit
  at. The audit process ISO 19011

   b. Regulatory standards related to SI:
• Appendix GMP 11
• US FDA CFR Part 21 211
• US FDA CFR part 21 11

2 - Case study: building an audit reference SI / SA

3 - Case Study: audit agenda of the construction of a production SI

4 - Inspection of computerized systems: preparation, implementation, monitoring

5 - Case Study: answers to inspection remarks

6 - Case study: analysis of inspection returns on SI

7 - Debriefing / Training Evaluation

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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