International Regulations for Manufacturing of Sterile Medicinal Producs

Réf. : THF4

Intervenant(s) : Emmanuel GOURVIL or Régis LETHUILLIER or Laurent MERLI or Pierre DEVAUX
Length : 14 hours (2 days)
Price : 1200
Trained people : 2025 - 95
Satisfaction rate : 91.1 %

Trainings EN

Type of training

In-house or inter-site

Target audience

Quality Assurance and Sterility Assurance managers and teams, Production managers and operators, Managers and support services teams (Utilities, Industrial Transfer, Qualification/Validation...), Quality Control Managers and Technicians in the pharmaceutical, biotechnological industries whether in human or animal health

Pre-requisites

no pre-requisites

Teaching goals

  • Understand and integrate the regulatory innovations described in Annex 1 of the
    European GMPs
  • Be able to implement them as part of your activities
  • Take into account the significant differences between the major global standards in this area: European GMPs Appendix 1, FDA Guidance 2004 – Sterile Drug Products Produced By Aseptic Processing, Japanese Pharmacopoeia 18th edition: 2024

Content of the training course

  • Reference the various international regulatory texts
  • Describe the historical evolution of Annex 1 of European GMPs and its latest revision process
  • Distinguish in the latest document published in Annex 1 its different chapters
  • Recognize different contaminants
  • List the key points of each chapter 1, 2, 3 and 4 of Annex 1 version August 2022
  • Identify new sections and confirm requirements for historical sections of these chapters
  • List the key points of each chapter 5, 6 and 7 of Annex 1 version August 2022
  • Identify new sections and confirm requirements for historical sections of these chapters
  • List the key points of Chapter 8 of Annex 1 version August 2022
  • Identify new sections and confirm requirements for historical sections of this chapter
  • List the key points of each chapter 9, 10 and 11 of Annex 1 version August 2022
  • Identify new sections and confirm requirements for historical sections of these chapters
  • Compare American, European and Japanese regulatory texts and discern differences for the topics covered in Appendix 1

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
  • Training certificate
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.