.何年にもわたる考察、書き直し、改訂の後、欧州委員会は附属書1の最終バージョンをリリースしました。このオンデマンドウェビナーでは、許可される注射用水(WFI)の製造方法に関するグローバルな薬局方の規制と、必要な分析に対する附属書1の影響について説明します。
プレゼンターは、注射用水の常温生産に関連するGood Manufacturing Practice(GMP)の新しいガイドラインについて説明します。また、附属書1が薬局方調和に与える影響についても説明します。
About the presenter :
Jim Cannon – Head of OEM & Markets, METTLER TOLEDO Thornton
After receiving a B.S. in Biology, he continued with graduate degrees in Microbiology and Biophysics, and an MBA in Marketing and International Management. Mr. Cannon has over 35 years of experience in the management, design, and development of ultrapure water treatment and technology. This includes measuring differential conductivity and UV oxidation for the detection of TOC in UPW and the design and commercialization of electrodeionization modules.
Mr. Cannon is currently involved in the standards and regulatory organizations for the semiconductor, photovoltaic and pharmaceutical markets, including the facilities and liquids committee, Reclaim/Reuse/Recycle Task Force and the UPW task Force. .