A3P

Log in
white bpf Regulatory update and state of the art for the manufacture of sterile pharmaceutical products

BPF04      
PUBLIC
- Technician and part of the pharmaceutical, biotechnology and associates involved in the production of clean and sterile products for human, veterinary or experimental
OBJECTIFS
• Update on (latest) regulatory texts and "state of the art" documents for the manufacture of sterile pharmaceuticals.
• Comment on expected interpretations.

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
1 day
 


PROCHAINE SESSION
2018


FORMATEUR
Patrick Turlier


TARIF
800 € HT
(Déjeuner inclus)


PICTO telechargerPDF 01

inscriptionbpf
The regulatory texts Europe (GMP, Pharm. Eur.) And US (Guidelines, USP) as well as those forming part of the state of the art applicable to the manufacture of sterile pharmaceutical products will be studied. Items subject to interpretation or requiring further explanation will be addressed.
The new Annex 1 (subject to publication) will be commented upon as well as approaches to regulatory inspections of sterile products.

Applicable statutory or reference documents

• EMA - Guideline on manufacturing of the final dosage form (2017)
• US Guidance for industry for the submission of documentation for sterilization process validation for applications for human and veterinary drug products - Nov. 1994
• US Guidance for the industry sterile drug products produced by aseptic processing cGMP Sept 2004
• US Guidance for industry container and closure system integrity testing in place of sterility testing - 2008 Fev XNUMX
• EU GMP with Annexes 1 and 17
• European Pharmacopoeia and USP

 

Practical aspects

• Air class (integrity test, speed, laminarity)
• Particulate monitoring
• Microbiological monitoring
• Biocharge - Sterilizing filtration
• Simulation of aseptic processes
• Finished products and controls
• Conclusions
• Returns of inspections / injunctions / reminders of contracts
s

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.
No Declaration: 82 69 13448 69 Pref. Region Auvergne Rhône-Alpes
SARL au capital de 10 000 Euros Siret 451 934 541 00025

A3P TRAINING 2018

Knowledge enhancement and its mastery

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

couv2018

2018 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