Computerized Systems
Cloud Computing et règlementation pharmaceutique
SI01

Date

March 22 2018

7 h face-to-face

Effective work

Formative

Jean-Louis Jouve

16,8
/ 20

Price

800 € HT

(Déjeuner inclus)

Objectives

- To understand the concept of "cloud computing" and its different characteristics.
- Understand pharmaceutical regulation (GxP) and its constraints on computerized systems in "cloud" mode.
- Evaluate the regulatory risks of different cloud proposals (IAAS, PAAS, SAAS) using examples.
- Derive the associated qualification / validation and risk management strategies.

Public

  • Beginner
  • Intermediate
  • Expert

- Quality assurance
- Validation and IT service

Programs

Cloud computing is becoming increasingly important in the healthcare IT landscape through the outsourcing of IT resources and the on-demand use of regulated software. With its certain advantages (scalability, cost control ...), cloud computing also has particular constraints related to its use in a regulated context.
The purpose of this training, based on case studies inspired by industrial experiences, is to take stock of the different modes of cloud computing, to know their weak points with regard to the applicable regulations and to to deduce a suitable risk management plan.

Reminders and definitions

  • Cloud computing
    Definitions and technology, the different offers: IAAS, PAAS, SAAS, advantages and disadvantages

 

  • The regulations applicable to Computerized Systems (EU and FDA):
    General principles and specific to the cloud (concept of electronic registration, open / closed system, responsibilities, outsourcing, etc.)


Études de cas

  • Infrastructure as a Service (IAAS):
    We propose to modernize and outsource your IT infrastructure to a provider that offers a virtualized architecture of the "cloud" type:

    • What are the risks associated with such a project?
    • How to tackle 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 associated risks? What audit approach?
    • Which approach of qualification / validation?

Assessment of acquired knowledge and evaluation of improvement actions undertaken and / or envisaged

Questionnaire de satisfaction

Program PDF version

To download the program of this training in PDF format, please click on the button below.

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
* Average score given by previous trainees

JOUVE

Jean-Louis JOUVE - COETIC

Engineer graduated from ESCIL and Lyon 1 University in Analytical Chemistry (DEA), he is, since November 2004, manager and principal consultant of Coetic, a consulting and expertise company dedicated to regulated industries (pharmaceutical, biotechnology, active pharmaceutical ingredients and medical devices).
In parallel, he has been involved in several regulatory compliance projects for computerized and automated systems.
He is also responsible for the A3P eCompliance GIC (Electronic Compliance) and sits on the A3P Board of Directors.
As an expert, he has been invited as a speaker at several international conferences and seminars and is the author of several scientific articles and publications.

Educational medium

At the beginning of the session, through a questionnaire, the trainer analyzes the level of knowledge of the professionals on the subject as well as their expectations of the knowledge to be acquired. The trainer adapts the training program according to the profile of the different participants. Time is spent exchanging experiences between participants and with the trainer.

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.

Referencing the DataDock

Single database that refers to training organizations that meet the criteria established by the funders.
Evidence of the proper application by the structures of the criteria set by the quality decree. The latter specifies how the training funders (OPCA) must ensure the capacity of the training organizations to provide quality training actions.

This referencing certifies the quality of our training according to 6 criteria and 21 indicators defined at national level by the funders.
Guarantees :
- The precise identification of the objectives of the training and its adaptation to the trained public.
- Adaptation of the reception, pedagogical monitoring and evaluation systems to trainee audiences.
- Adequacy of pedagogical, technical and supervisory resources to the training offer.
- The professional qualification and the in-service training of the staff responsible for training.
- The conditions for informing the public about the training offer, its access times and the results obtained.
- Taking into account the assessments made by trainees.

To register for this training, please return the registration form.

All our courses take place at 30 rue Pré-Gaudry in Lyon 7ème and start at 8h30 and end between 17h and 18h.

Contact

According to your requirements and your preferences, you can contact Marion Provini:

Phone: +33 (0)4 37 28 30 49
Fax: +33 (0)4 37 28 30 60
E-mail : mprovini@a3pservices.com
Mail: A3P Training, 30 rue Pré-Gaudry - Lyon 69007
On site: 30 rue Pré-Gaudry, Lyon, from Monday to Friday

Accessibility

50

Hotels nearby

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Séjours & Affaires Hotel - Park Avenue
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5 min walk
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4 metro stops (Part Dieu)

Hotel Séjours & Affaires - Saint Nicolas
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4 metro stops (Part Dieu)
Offer Training A3P

Hotel Séjours & Affaires - Saxony Gambetta
34 Great Street of the Guillotière, 69007 Lyon - Tel: + 33 (0) 4 72 71 91 92
2 metro stops (Saxe Gambetta)
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Hotels ***

Park And Suites Lyon Gerland
175 avenue Jean Jaurès, Lyon 69007 - Tel: + 33 (0) 4 37 37 25 25
5 min walk

Mercure Lyon Beaux Arts Centre
73-75 rue du Président Edouard Herriot, Lyon 69002 - Tel: + 33 (0) 4 78 38 09 50
30 2 min (2 different subway lines)

Hotels ****

Novotel Gerland
70 avenue Leclerc, 69007 Lyon - Tel (+ 33) 4 72 71 11 11
20 min walk

Quality Suites Lyon 7
Felix Brown Street 7, 69007 Lyon - Tel: + 33 (0) 4 37 37 23 70
3 min walk

Novotel La Part Dieu
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15 minutes by car
4 subway stops

Mercure Lyon Part Dieu
50 rue de la Villette, 69003 Lyon - Tel: + 33 (0) 4 72 68 25 20
15 minutes by car
4 subway stops

Novotel Confluence
3 St. Paul Montrochet, 69002 Lyon - Tel: + 33 (0) 4 37 23 64 00
30 min tram and bus