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GMP, GLP, and GCP – Fundamentals and Advanced Requirements in the Pharmaceutical Industry

Veranstaltungsdaten

The pharmaceutical industry is a specially regulated area. Detailed expectations have been laid down in the form of GMP (good manufacturing practice) regulations to ensure the quality of the manufacturing process as well as to control the quality of the final medicinal products. In this course, you will learn the requirements and expectations of the different GMP regulations. We will discuss several aspects of how to introduce and manage these expectations to demonstrate the quality of the product.

This course will provide an overview of quality management, quality control, and important points in the production of medicinal products. Among the issues that will be addressed are also the responsibilities in managing the quality of the products. Last but not least, we will briefly touch upon clinical trials and how to release the products into the market.
Additionally, we will discuss possibilities of entering the pharmaceutical industry after completing your dissertation and what you might expect.

Intended Learning Outcomes

• You will learn what GMP means.
• You will receive basic knowledge of the regulatory requirements and how to manage them.
• You will be aware in some detail of the expectations involved in the manufacturing, quality management (quality assurance), and quality control of medicinal products.
• You will know what the basic expectations are for the quality of medicinal products.
• You will have an overview of the interactions between different departments and processes.
• You will get an initial glimpse into the manufacturing of vaccines.

Didactic Methods

Presentation, discussion, practical examples

Requirements 

Proficiency in English at the B2 level of competency is required.

Date

September 12, 2024, 9 am–5 pm, and
September 13, 2024, 9 am–5 pm

Target group

Doctoral candidates and postdocs from the life and natural sciences

Modalities

Maximum number of 14 participants
Internal 50 EUR
External 150 EUR

Registration

Please register until August 28, 2024 using the online registration form.