A3P

Log in
white systemesinfo Audit and solving the problems of "data integrity" to the quality control laboratory

SI05      

PUBLIC
- Insurer Quality
- Personal computer
- Laboratory Personnel / Quality Control

OBJECTIFS
• Clarify the definition of this term and expectations of regulatory authorities on the subject.
• Evaluate, through the case study of the quality control laboratory, the various risks associated with the "Data Integrity".
• Provide technical and human resources to manage those risks.
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

new


DUREE
1 day


DATE
8 2017 June

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


TARIF
800 € HT
(Déjeuner inclus)


PICTO telechargerPDF 01


inscriptionsi

Observations inspection on the "Data Integrity" are becoming more numerous and concern not only emerging countries; these remarks reveal significant gaps in the management of electronic data or paper for which manufacturers must have the means of effective prevention.
The proposed training will recall the main regulatory requirements on this issue and offer, through a case study on laboratory recordings, to acquaint participants with the appropriate means of control in this area and their possible application in business

MORNING:

Definition (s) of the "data integrity" and related terms: life cycle of the data ...

History and regulatory references:
• Main enforceable regulations
• Examples of inspection Returns

Case study :
• Risk analysis "Data Integrity" on various data recording processlaboratory paper, direct entry, excel sheet, instrument connection management systemlaboratory...

AFTERNOON:

Case study (continued)

Synthesis on how prevention: behavioral, organizational, technical ...

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

logo a3p training vf

Knowledge enhancement and its mastery

Throughout the year, A3P brings together
experts to offer you professionals quality
training sessions.

couv2017 200 shadow

2017 training program

 

letterA3P Training newsletter

 
E-mail.

Tel.
Fax.

a3pformation@a3pservices.com
33 + (0) 4 37 28 30 49
33 + (0) 4 37 28 30 60

Hotels near A3P Training Site

local

A unique training space in the heart of Lyon

All our courses are held in modern and welcoming space at 30 rue Pre Gaudry Lyon 7ème.

pause

If you want to rent our space, you will find below all the necessary information.

More information on renting