Computerized Systems

Validation of computerized systems:
basics to optimization

SI03

Date

May 17

7 h face-to-face

Effective work

Formative

Jean-Louis Jouve

15
/ 20

Price

800 € HT

(Déjeuner inclus)

Objectives

- Master the key steps of the validation of computerized systems.
- Gain productivity on this subject.

Public

  • Beginner
  • Intermediate
  • Expert

Quality assurance and IT

Programs

The validation of computerized systems is based on widely known standards and standards; however, taken literally, these standards can generate significant workload and questionable efficiency.

Comment aborder pratiquement une validation de système informatisé ?
Quels sont les points critiques à maîtriser ?
Quels sont les points critiques à maîtriser ?
La formation se chargera de répondre à ces questions à partir d’exemples et d’exercices réalisés en commun.

Principes directeurs de la validation des systèmes informatisés

From 1983's Blue Book to Today, How Do Validation Techniques Work?
evolved?

1. Principaux référentiels européens et américains :

  • EU GMP Appendix 11
  • 21 CFR Part 210-211
  • 21 CFR Part 11


2. Cycle de vie des applications et validation :

  • Project documents: URS, FS, etc. :
  • What level of detail?
  • How to reuse supplier documents?
  • Criticality and risk analysis: How to get to the point? Tools and optimization techniques
  • Validation documentation: "supplier validation package", writing protocols and scripts, automated tools


3. La gestion du changement et des écarts de validation


4. Peut-on évaluer la performance de la validation ? Quels sont les métriques utiles ?

A case study will be proposed in the red thread of the training to illustrate the theoretical debate on
phases of specification, risk analysis and qualification

Assessment of acquired knowledge and assessment of improvement actions undertakenand / 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 the different methods and references.

Exercices.

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

Hotels **

Séjours & Affaires Hotel - Park Avenue
2 rue Madeleine Fourcade, 69007 Lyon - Tel: + 33 (0) 4 37 65 59 59
5 min walk
Offer Training A3P

Appart City Lyon - Part Dieu Villette
6 Avenue Lacassagne, 69003 Lyon - Tel: + 33 (0) 4 37 91 99 21
4 metro stops (Part Dieu)

Hotel Séjours & Affaires - Saint Nicolas
90 Boulevard Vivier Merle, 69003 Lyon - Tel: + 33 (0) 4 37 48 24 24
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)
Offer Training A3P

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
47 boulevard Vivier Merle, Lyon 69003 - Tel: + 33 (0) 4 72 13 51 51
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