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Titre

Quality in Pharmaceuticals -- FULL --

Dates

06.05.2021, 08:30-12:00 and 13:30-16:30, and 07.05.2021, 09:00-12:30

Lang

Workshop language is English

Organisateur(s)/trice(s)

Intervenant-e-s

Ms Ann Stroemberg, Director Global Development Compliance, Global QA at Ferring Pharmaceuticals A/S, Copenhague, Danemark

Dr François-Xavier Abellan, Associate Director GQA Quality System at Ferring Pharmaceuticals, Saint-Prex, Switzerland

Mr Julien Boccadoro, CMC Project Leader at Ferring Pharmaceuticals, Saint-Prex, Switzerland

Description

Pharmaceuticals are considered as the most highly regulated industries worldwide.

Quality, from research and development stages through production, testing and post-marketing surveillance by applying the principles of Quality by Design (QbD), Quality Assurance (QA), and the Good Practices (GxPs), is essential to ensure the safety, quality and efficacy of medicines.

The Quality in Pharmaceuticals course is designed for people who have no knowledge of the GxP in the pharmaceutical industry.

The Objective with this course is to understand the importance of Quality in the development and manufacturing of products in the pharmaceutical industry:

· You get to know the most important pharmaceutical regulations and their application areas

· You get a basic overview and understanding of the quality requirements applied in the pharmaceutical industry

· You get an overview of Pharmaceutical Development and Quality by Design principles

You become familiar with specific terms in the field of GxP and their meaning

Programme

Day 1
When	Who	What
8.30 – 9.00	Francois-Xavier Abellan	Welcome and Ferring presentation
9.00 – 10.00	Ann Stroemberg	Quality in R&D part I
10.00 – 10.15	Break
10.15 – 11.00	Ann Stroemberg	Quality in R&D part II
11.00 – 11.15	Break
11.15 – 12.00	Ann Stroemberg	Quality in R&D part III
12.00 – 13.30	Lunch
13.30 – 14.30	Francois-Xavier Abellan	Quality in Manufacturing part I
14.30 – 14.45	Break
14.45 – 15.00	Francois-Xavier Abellan	Quality in Manufacturing part II
15.00 – 15.15	Break
15.15 – 16.00	Francois-Xavier Abellan	Quality in Manufacturing part III
16.00-16.30	Francois-Xavier Abellan	Q&A – Feedback - Closing

Day 2
When	Who	What
9.00 – 10.00	Julien Boccadoro	CMC development and Quality by Design part I
10.00 – 10.15	Break
10.15 – 11.00	Julien Boccadoro	CMC development and Quality by Design part II
11.00 – 11.15	Break
11.15 – 12.00	Julien Boccadoro	CMC development and Quality by Design part III
12.00 - 12.30	Julien Boccadoro	Q&A – Feedback - Closing

Lieu

Microsoft Teams sessions

Information

Places

Délai d'inscription

30.04.2021

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