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Barrier technologies in sterile production environments

Speakers : Patrick COPPENS
Length : 2 days - (14 hours)
Dates : 10 and 11 September 2024
Price : 1200

Training

Type of training

In-house

Target audience

Production, Maintenance, Qualification / Validation, Sterility Assurance, Operational Quality Assurance

Pre-requisites

No

Training accessible to people with disabilities

Yes

Teaching goals

  • Identify and know the regulatory requirements
  • Mastering aseptic practices and identifying associated risks
  • Know the technical fundamentals and constraints Annex 1
  • Identify areas of concern
  • To be able to put into practice the notions acquired on the site

Content of the training course

  • Reminder of regulatory requirements:
    • Eudralex – volume 4 Good Manufacturing Practice (GMP) guideline
    • Annex 1 GMP
  • Definition, technologies, aseptic practices and associated risks:
    • Definition and differences between RABS vs Isolator
    • Aseptic practices
    • Decontamination update
  • Technical fundamentals – User expectations and constraints
    • Isolator project, the importance of understanding customer processes
    • Classification and management of air in the isolator / in the ZAC
    • Glove management
    • EMS
    • Management of external connections and inputs/outputs
    • Mock up / FAT / SAT
  • Point of vigilance:
    • Validation process of disinfection cycle in the isolator
    • Manufacturing process / specific handling
    • Management of moving parts
    • Management of environmental variables
  • To be able to put into practice the notions acquired on the site

How the course is organised

Teaching and technical tools

  • Training materials and regulatory documents.
  • Theoretical input, concrete case examples
  • Participatory pedagogy
  • Question and answer sessions
  • Self-assessment using a grid

Tool for monitoring the implementation of the training results assessment

  • Attendance sheets.
  • Test of knowledge acquisition
  • Training certificate.

Registration and formalities

Registration

For all intra or inter-company registrations, please send your request to the following email address : contact@theraxel.fr . An acknowledgment of receipt of your request will be sent to you as soon as possible

Training place

Our training takes place in our premises located at 16 rue Sainte-Marguerite – 21200 Beaune. Sessions start at 9 a.m. and end at 5 p.m.

Our training courses are accessible to people with disabilities. For people with reduced mobility, please contact our Handicap representative, Maryline PERRAUD: 03.80.25.94.30.

Registration conditions

A minimum of 5 participants is required for the training to be provided. Below, THERAXEL reserves the right to postpone the scheduled session.

Upon receipt of your registration, Theraxel will send you an acknowledgment of receipt. The training agreement will be sent to you at the latest 1 month before the start of the training.

After the training has taken place, we will send you the invoice as well as the training certificate. From the date of issue of the invoice, payment must be made within 30 days at the latest.

Terms of cancelation

In the event of withdrawal by the beneficiary before the start of the training program: Within more than 1 month before the start of the training: 50% of the cost of the training is due.

Within a period of between 1 month and 2 weeks before the start of the training: 70% of the cost of the training is due.

Within a period of less than 2 weeks before the start of the training: 100% of the cost of the training is due.

In the event of a cancellation of less than 2 weeks, following the current health crisis linked to COVID-19, upon presentation of medical proof, the amount of the training is not due.

Our prices

All prices are indicated in euros excluding taxes. The applicable VAT rate is 20%.

The prices indicated are in effect for the current year, and applicable for inter-company training.

The prices indicated are per participant and include the educational cost of the training, materials, lunch and breaks.

For intra-company requests, the request will be the subject of a personalized quote adapted to your needs. Contact us for more information.

Practical information

  • Contact :

For any information, you can contact:

Maryline PERRAUD, Disability Representative
Séverine LAURY, Administrative Referent

Elodie PASTRE and Pierre DEVAUX, Educational Referents

Phone : 03.80.25.94.30

Mail : contact@theraxel.fr

Courrier : 16 Rue Sainte-Marguerite – 21200 Beaune

Opening hours : from monday to  friday  – 9 am to 5 am.