About the webinar
Water is the most widely used substance, raw material or starting material in the production, processing and formulation of pharmaceutical products. The presentation will provide an overview a process for the Commissioning and Qualification of a WFI system following the approach described in the baseline guide, and discuss how the use of instrumentation can be integrated into the approach.
About the Presenters.
Nick is a Senior Specialist (QA) at Amgen, supporting International Distribution Quality.Nick began working in Amgen in the engineering department in 2006, moving to Quality in 2009. Prior to joining Amgen, he worked for Glaxo in their technical support group supporting overseas projects. Nick is the current chair of the ISPE HVAC and Sustainability Community of Practice Committee, and a member of the ISPE Guidance Document Committee. He has contributed to several of the ISPE guidance documents including the HVAC Good Practice Guide, CTC Mapping Good Practice Guide and the Water and Steam Commissioning Good Practice Guide.
Nissan Cohen -A worldwide expert, with 40 years experience, in Total Organic Carbon (TOC), high purity, ultrapure, reclaim and recycle water systems, with profound expertise in instrumentation, automation, and organic contamination oxidation systems using ozone, UV, ion exchange and catalysts.Accomplished writer of over 35 technical articles. Contributing author and Chapter Leader of “Baseline Guide for Pharmaceutical Water and Steam Systems”. Co-chairman and Coordinating Author of the “Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems” Good Practice Guide, Contributing author to the Good Practice Guide on Ozone.
5 авг 2024
