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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.

We are pleased to announce that Beckman Coulter, Inc. will host a webinar titled "Explanation of the International Standard for Clean Rooms (ISO 14644-1) and Solutions Suitable for Environmental Monitoring," along with an introduction to the new particle counter MET ONE 3400+. Organizer: Beckman Coulter, Inc. Date and Time: October 29, 2020 (Thursday) 15:00 - 16:30 In this seminar, we will welcome Mr. Yasuyasu Yamakawa, representative of GMP Research, who has extensive experience in consulting on GMP and regulatory trends in pharmaceutical manufacturing, as our speaker. He will provide explanations, including comparisons with the old standard (1999). He will also mention the main differences with the Japanese Industrial Standard JIS B 9920-1: 2019 (Clean Rooms and Associated Controlled Environments - Part 1: Classification of Air Cleanliness by Particle Concentration), which is based on ISO 14644-1: 2015. In the second part, we will introduce the new product MET ONE 3400+, developed for environmental monitoring of clean rooms in compliance with GMP, presented by Beckman Coulter.