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Classification and Routine Environmental Monitoring for GMP Cleanrooms 3 года назад


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Classification and Routine Environmental Monitoring for GMP Cleanrooms

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: Classification and Routine Environmental Monitoring for GMP Cleanrooms Webinar Abstract: The various GMP guidelines and International ISO standards around GMP cleanrooms are complex and often appear to give conflicting advice, leading to confusion and sometimes incorrect interpretation. In the case of Routine Environmental Monitoring, there is very little prescriptive advice and this lack of direct guidance leaves users struggling to know what to do and the temptation is to either create over-burdensome monitoring programs or to try to simply use the same monitoring plan as is used for classification. Both are incorrect. This webinar discusses the differences between GMP Cleanroom Classification and Routine Environmental Monitoring and explains how Beckman Coulter can help. Earn PACE Credits: 1. Make sure you’re a registered member of LabRoots (https://www.labroots.com/ms/webinar/g...) 2. Watch the webinar on YouTube or on the LabRoots Website (https://www.labroots.com/ms/webinar/g...) 3. Click Here to get your PACE credits (Expiration date – September 09, 2022): (https://www.labroots.com/credit/pace-...) LabRoots on Social: Facebook:   / labrootsinc   Twitter:   / labroots   LinkedIn:   / labroots   Instagram:   / labrootsinc   Pinterest:   / labroots   SnapChat: labroots_inc

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