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white process Maîtrise de la chaîne du froid

 

PROC09      

PUBLIC
- Quality Personnel
- Personal storage services / logistics

sectors:
- Pharma / Biotech
- Storage / Distribution
- API and excipients manufacturers
- Carriers

.

OBJECTIFS
• Acquire the basic techniques required to set up a effective cold chain and meets specific characteristics (eg passive and active systems).
• Know how to identify risks specific to the cold chain and deploy an impact assessment method in case of deviation Cold Chain.
• Show good practices (new BPD).

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.
After the course, participants will receive paper and digital copies of the course's content.

Study of practical cases.

 

PROGRAM  

 

new


DUREE
2 days


DATE
28 and 29 2017 November


FORMATEUR

Agnes FELIX-PICAUT
consultant Trainer 


TARIF
1 200 € HT
(Lunch included)



PICTO telechargerPDF 01


inscriptionprocess
The training will acquire the basic techniques required to set up a effective cold chain at different stages: during the establishment of a cold chain and its qualification, reception, storage, preparation of orders and upon delivery.

1 DAY

MORNING
• The cold chain and sensitivity of products to T ° overruns
• Equipment used, their use, control
• The maintenance of quality assurance to the patient
• The packaging used

AFTERNOON
Deployment
• The active transportation in cold or cool packs: advantages / disadvantages
• Monitoring of the cold chain: T ° recorders
• Customer delivery terms
• Monitor quality of raw material manufacturer (demerit)
• expectations of Expression (CoC quality and schedule)

2 DAY

MORNING: Theoretical Phase
• Define what the TOR (Time Out Refrigeration)
• Establish all steps that follow the product from manufacturer to patient
• Identify risk zones From examples of marketed products and a study of the differences, non-conformities and complaints handled by a site hazard identification and impact on the product and / or patient
• Getting to define actions to reduce risks to the maximum
• Formalize operational documents responding to the problem, on the receiving store chain (for example: preparation protocol packaging / sales order processing, transportation and delivery / receipt process by recipients, wholesalers, pharmacies, hospitals ...)

AFTER - MIDI: Practical Phase
Study of types of usable material: Example storage enclosure 2-8 ° C, packaging, transport, recording T ° mobile and fixed Case study: analysis of situations by trainees, identifying possible gaps, answers inflows, enrichment the facilitator and drafting a mini collective action plan

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
Agnes FELIX-PICAUT
agnesfelixpicautconsultant Trainer Pharmacist and former responsible development and quality control of Janssen-Cilag, she was responsible pharmacist and director for quality 15 years of PHARMALOG company (Geodis Group).

As such, it had to manage the implementation and maintenance of the quality system (includes daily BPD), the interface with contractors and the authorities (ANSM / ANSMV).

She is now a consultant specializing in the distribution of pharmaceutical products.


A3P training:
PROC09- Cold Chain Master

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