Seminar on manufacturing and quality management of aseptic drugs based on the analysis of trends in international GMP regulations will be held in September

Aug 13, 2025

The 'Seminar on the Manufacture and Quality Management of Aseptic Drugs Based on Analysis of International GMP Regulations' will be held in Gangnam, Seoul, Novotel Ambassador on September 11.

The seminar, hosted by the Ministry of Food and Drug Safety and organized by the Korea Pharmaceutical and Bio Association , is an expert Dr. to help workers at the aseptic drug manufacturing center find practical countermeasures as the PIC/SGMP Annex 1 revision and the "Regulations on Drug Manufacturing and Quality Control" notice of the Ministry of Food and Drug Safety are revised. We will start Ingrid Healther and share know-how. The speaker has served as Director of R&D, Manufacturing and Quality GMP at Fresenius Kabi AG and Pharmaplan GmbH, and has worked on more than 400 projects in more than 40 countries, including EU and FDA GMP Regulation Consulting.

세미나 오전 세션에는 ▲Annex1 Changes Future Sterile Manufacturing·A brief summary and overview ▲Contamination Control Strategy· Background and Targets ▲Introduction to a CCS - Document template: Scope, Format and how to use it이 진행된다.

이어 오후 세션에서는 ▲Pametric Release - regulatory requirements and expectations and practical approach ▲Filter Validation ▲UPSIT·regulatory background, practical aspects가 다뤄진다. Each session will provide practical help to companies, such as providing an opportunity to review in-depth what was difficult in the process of introducing new regulations through preliminary questions by subject.

The seminar can be participated through pre-registration by the 22nd of this month, and no more than two people can apply for each manufacturer of aseptic drugs. Simultaneous interpretation is provided to enhance the understanding of the seminar and is free of charge.

This article was translated by Naver AI translator.