Annex 1 - How It Will Impact You
Changes to Ambient WFI Production
After years of discussion, rewrites, and revisions, the European Commission has released the final version of Annex 1. This on-demand webinar looks at global pharmacopeia regulations for the allowed methods of producing WFI and the impact of Annex 1 on the required analytics.
The presenter explains the new guidelines for Good Manufacturing Practice (GMP) as they relate to ambient production of Water for Injection. How Annex 1 is affecting pharmacopeia harmonization is also discussed.
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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. .
