Target Audience

This event is aimed at all those interested in GMP-compliant manufacturing, quality assurance, and approval of biological products, and who want to acquire the necessary basic knowledge for this.

Objectives

Especially in biotechnology, there are specific challenges in meeting the legal requirements for production and quality assurance. Therefore, this seminar focuses intensively on the particularities that must be considered when manufacturing biopharmaceuticals to ensure GMP compliance. One goal is to convey the basics of pharmaceutical biotechnology to non-biotechnologists and career changers, and to explain the specific application possibilities of biotechnology in the GMP environment.

In addition to topics related to production, such as facilities, handling of cell banks, and fermentation, aspects of quality assurance and clinical trial samples are also covered.

Furthermore, current regulatory requirements will be explained by a GMP inspector, and speakers from industry and research will offer the opportunity to discuss their perspectives. Through an inspection practice report, you will learn where common weaknesses occur in the practical implementation of the guidelines and how to address them.