Presented By:
Tony Harrison

Speaker Biography:
Tony held the Convenorship of the ISO Working Group revising ISO 14698-1 & -2 for microbial control in cleanrooms and was the UK subject matter expert to the ISO Working Group who issued the 2015 revised versions of the ISO 14644-1 & -2 documents for cleanroom classification at the heart of the aseptic manufacturing chapters of both the European GMP and the USA cGMP documents. Tony was joint editor on the ISPE Guide to Ozone Sanitization of Pharmaceutical Water Systems and was also chief editor of the PHSS Best Practice Guide for Cleanroom Monitoring. Tony is employed by Beckman Coulter Life Sciences as a Senior Manager.

Webinar:
Changes to USP 643 Total Organic Carbon for Pharmaceutical Grade Waters

Webinar Abstract:
A revised version of the USP chapter on Total Organic Carbon (TOC) USP643 was published recently and will become official on 1st May 2021. This paper gives an overview of this new USP chapter and discusses the reasoning behind the difference in the System Suitability Test materials called for in USP 643 and those in the Japanese JP16.


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