"Comparison of Aseptic Pharmaceutical Manufacturing Environment Requirements in Japan, the United States, and the EU (Part 1) and Introduction to Suitable Solutions for Environmental Monitoring" and a webinar introducing the new particle counter MET ONE 3400+.

Organizer: Beckman Coulter, Inc.
Date and Time: November 12, 2020 (Thursday) 15:00 - 16:30
Participation Fee: Free
Location: Zoom Webinar *Pre-registration required
Overview:
In this seminar, we will welcome Mr. Yasuhiro Yamakawa, representative of GMP Research, as a speaker to explain the requirements for the manufacturing environment of sterile pharmaceuticals, comparing the contents of these guidelines.
Additionally, since the EU-GMP Annex 1 (Manufacturing of Sterile Medicinal Products) is currently under revision, he will also mention the changes in the revised draft published in February 2020 (the first draft was published in December 2017).
<Main Content>
- Overview and characteristics of GMP guidance for sterile pharmaceutical manufacturing
- Comparison of manufacturing environment requirements for sterile pharmaceuticals
- Cleanliness classifications and limits (particles, microorganisms)
In the second part, we will introduce a new product, MET ONE 3400+, developed for environmental monitoring of clean rooms in compliance with GMP, presented by Beckman Coulter.

Date and time | Thursday, Nov 12, 2020 03:00 PM ~ 04:30 PM |
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Entry fee | Free |
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