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white bpf Understand and implement the requirements of the new Annex 1 of the European GMPs  
BPF10      
PUBLIC
Framework for the pharmaceutical and biotechnology industries concerned with the manufacture of clean and sterile products for human, veterinary or experimental use

PRE REQUIRED
Participants should already be involved in the quality, validation, quality control aspects of their sites, be familiar with the 2008 version of Annex 1 and have practical knowledge of the approaches / tools for analyzing risk

OBJECTIFS
• Understand the significant differences between the 2008 version and the new version
Measure the industrial implications of changes in the new version
To emerge from the training with practical case studies to respond on site to certain changes including those related to risk analyzes
.

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.

 

PROGRAM   new

DUREE
2 days


PROCHAINE SESSION
2018

FORMATEUR
Pierre Devaux

Marc BESSON 


TARIF
1 200 € HT
(Lunch included)


PICTO telechargerPDF 01
inscriptionbpf

1 DAY


Day 1 - Morning:
- Objectives, tour de table, training agenda
- Update on international regulations
- The various contaminants to be controlled in the ZACs
- Presentation of the new version and comparison with version 2008


Day 1 - Afternoon:

- Presentation of the new version and comparison with version 2008

2 DAY


Day 2 - Morning:
- Discussions / exchanges on specific topics to be defined depending on exchanges with other associations such as ISPE, PHSS, PDA .....
- Work in sub-groups on specific subjects


Day 2 - Afternoon:

- Restitution of sub-groups
- conclusions

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
Pierre Devaux
pierredevauxExpert Control of Contamination
An expert in contamination control, he performs audit, consulting and training missions for the Healthcare Industries around UPS Consultants around the following themes: validation of cleaning, cleaning of premises, good Aseptic practices, implementation Place of risk analysis to control the contamination of manufacturing processes, GMPs audits and investigation on problems of contamination of products.

Training A3P:
MC02 - Validation of production equipment cleaning processes in pharmaceutical industry
MC07 - Development of a bio-cleaning program in cleanrooms in GMP environment
MC08 - Contamination control in ZAC (sterile and non sterile)
BPF10Understand and implement the requirements of the new Annex 1 of the European GMPs

A3P TRAINING 2018

Knowledge enhancement and its mastery

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

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2018 training program

 

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