GMP Cleanroom Routine Environmental Monitoring & 21CFR part 11 Data Integrity

Описание: 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:
GMP Cleanroom Routine Environmental Monitoring & 21CFR part 11 Data Integrity

Webinar Abstract:
Routine Environmental Monitoring in GMP cleanrooms is a manual process and is usually complex, involving thousands of sample data points per month, manual data transcription and all too frequently data gaps and data integrity challenges. This webinar discusses the difference between cleanroom classification and routine environmental monitoring, outlines the FDA 21CFR part 11 ALCOA guidance and shows how the new MET ONE 3400+ non-viable air particle counter from Beckman Coulter Life Sciences can automate routine environmental monitoring programs to help manage data integrity challenges.

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