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International regulations for manufacturing sterile medicines

Réf. : THF4

Speakers : Emmanuel GOURVIL, Régis LETHUILLIER, Kénin ARHEL
Length : 14 hours (2 days)
Dates : 14 and 15 May 2024 or 25 and 26 June 2024
Price : 1200

Training

Type of training

In-house or inter-site

Target audience

Head Pharmacist, Quality control managers and technicians in the pharmaceutical, biotechnology, human and animal healthcare industries.

Pre-requisites

no pre-requisites

Training accessible to people with disabilities

Yes

Teaching goals

  • Understand and integrate the new regulations described in Annex 1 of the European GMPs.
  • Be able to implement them as part of your business
  • To take into account the significant differences between the main global benchmarks in this area: European GMPs Annex 1, FDA Guidance 2004 – Sterile Drug Products Produced By Aseptic Processing, Japanese Pharmacopoeia 17th edition: 2016

Content of the training course

  • Make reference to the different international regulatory texts
  • Describe the historical development of Annex 1 of the European GMPs and its latest revision process.
  • Be able to identify the different chapters in the last document published in Annex 1
  • Recognise the different contaminants
  • List the key points of each chapter 1, 2, 3 and 4 of the Draft Annex 1 of February 2020
  • Identify new sections and confirm the requirements for the original sections of these chapters
  • List the key points of each chapter 5, 6 and 7 of the Draft Annex 1 of February 2020
  • Identify new sections and confirm the requirements for the original sections of these chapters
  • List the key points of Chapter 8 of the Draft Annex 1 of February 2020
  • Identify new sections and confirm the requirements for the original sections of these chapters
  • List the key points of each chapter 9, 10 and 11 of the Draft Annex 1 of February 2020
  • Identify new sections and confirm the requirements for the original sections of these chapters
  • Compare the American, European and Japanese regulatory texts and establish the differences for the topics covered in Annex 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
  • Self-assessment using a grid

Tool for monitoring the implementation of the training results assessment

  • Attendance sheets.
  • Knowledge acquisition assessment test
  • Certificate of training.

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.