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white stopmicrobe particulate risk analysis in sterile injectable products

MC10      
PUBLIC
- QC Manager to control reception
- Process Development Manager (articles, process steps)
- Responsible for mirage services - visual inspection
- QA Managers in operational quality and quality suppliers
- Regulatory Compliance Manager and updating of regulatory files
- Monitoring Officer claims
- Engineering equipment Head
- Responsible for qualification validation

OBJECTIFS
• Edit key recommendations, detailed in the behavior in the prevention and detection of particles throughout the production chain, including suppliers.

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.
Studio work and in groups.

 

PROGRAM   NOTE MOYENNE
16given by previous interns 

DUREE
2 days


DATE
2018

FORMATEUR
Alain EUZEN


TARIF
1 200 € HT
(Lunch included)


PICTO telechargerPDF 01


inscriptionmc

The particulate risk is very real throughout the manufacturing chain sterile injectable products and associated medical devices. The work of sub-groups of experts as a Common Interest Group have revealed similarities in the means of control (prevention & detection) between suppliers, manufacturers, producers and analysts. Whenever a company faces the particulate risk through complaints, it is lot reminder of danger as criticality is high and maximal for the supervisory authorities in the delivery to patients.
Mastering the risk of presence of intrinsic or extrinsic particles is possible and demonstrable today from upstream to downstream production processes. The company holding the final liability of the product must have a standard and detailed recommendations to address this still controversial subject.

After an overview of the requirements and key definitions (GMP Pharmacopoeia, technical notes, ...), the program is divided into three parts.

1. Mapping methods or a rapid risk analysis (FMEA, or trees defects or ranking - filtering) throughout supply chain.

2. Establishment of decision trees on at least 4 basic process:
- The definition of levels of acceptance and rejection of packaging materials in contact with the products.
- The procedures to follow in case of discovery of particles throughout the power dosage form.
- Visual inspection and reinspection procedures.
- The processing of claims: risk patients (eg toxicopharmacologique).

3. The drafting group of detailed recommendations for rational standard and the "position" defended against authorities and in compliance with the safety of the final patient by each company.

Throughout the session, the sharing of experiences are expected and challenged race: identification and characterization of particles, levels of NQA / AQL used, risk analysis criteria - patient case of treatment of particles or pieces of glass, metal, this list is not exhaustive.

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

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