Serialization / Aggregation

Intervenant(s) : Jean-Louis JOUVE or Christophe Fagard
Length : 7 hours (1 day)
Price : 800
Trained people : 2025 - no session

Trainings EN

Type of training

In-house or inter-site

Target audience

Anyone involved in the serialization/aggregation process

Pre-requisites

no pre-requisites

Teaching goals

  • Understanding the regulatory context
  • Understand the impact of implementing a serialization system on production
  • Understand the impact of implementing a serialization system on information systems
  • Understand the impact of implementing a serialization system on quality assurance
  • How to structure a serialization IS specification

Content of the training course

  • Understanding the regulatory context
    • European regulation 2016/161 and related documents
    • Serialization in the pharmaceutical world
  • Understand the impact of implementing a serialization system on production
    • Equipment to be installed
    • Organization
  • Understand the impact of implementing a serialization system on information systems
    • What is an information system?
    • Mapping of affected automated and computerized systems
    • Computerized serialization systems
    • The GAMP®5 computerized system project approach
  • Understand the impact of implementing a serialization system on quality assurance
    • Possible deviations
    • Batch certification
    • Claims
  • How to structure a serialization IS specification
    • Examples of solutions
    • Computerized system compliance

How the course is organised

Teaching and technical tools

  • Training materials.
  • Theoretical presentations, examples of concrete cases
  • Practical application exercises
  • Question and answer sessions

Tool for monitoring the implementation of the training results assessment

  • Attendance sheets.
  • Assessment tests of the acquisition of knowledge
  • Certificate of training.
Download the training file

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 open-enrollment courses can be offered in Beaune (21200) or Dijon (21000).

For in-house training, please contact us.

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.

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.

People with disabilities

Accessibility for people with disabilities:

If you have a disability or are experiencing difficulties, you can contact our contact person: Maryline PERRAUD, at 03.80.25.94.30, so that we can study your request and adapt the form and content of the teaching methods implemented.

Practical information

  • Contact :

For any information, you can contact:

Séverine LAURY, Administrative contact person for the training department

Maryline PERRAUD, Disability Representative

Elodie PASTRE and Pierre DEVAUX, Educational Referents

Tél : 03.80.25.94.30

Mail : contact@theraxel.fr

Courrier : 16 Rue Sainte-Marguerite – 21200 Beaune

Sur place : du lundi au vendredi de 9h à 17h.