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16 Feb 2021Ended

GMP Environmental Monitoring for Pharmaceutical Clean Rooms

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Estimated Turnout

upto 100
Delegates
Based on previous editions

Editions

Feb 2021
+1 more editions

Frequency

Annual
Next edition likely in Feb 2022
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Learn regulations pertaining to environment monitoring program for pharma cleanroom, Ongoing monitoring practices, current air and surface monitoring .. Read more systems for the measurement of microbial contaminants in the clean room, gowning technique and aseptic practices. Hence a proper understanding and testing of the clean room environment and ongoing environmental monitoring of a clean room environment is necessary from a product compliance perspective. Attend this webinar to understand the various US and international regulatory requirements, the testing requirements for the various clean room classifications as well as the environmental monitoring of clean room environments. It will describe the Action and Alert Levels and how these levels are determined for a particular facility along with Corrective and Preventative Actions are defined. We will discuss all current air & surface monitoring systems for the measurement of non-viable particulate, microbial contaminants in the clean room . The subject of clean room contamination due to personnel is discussed including both gowning technique and aseptic practices. Then Ongoing monitoring practices for the clean room environment are discussed with respect to sampling frequency, sampling locations, and the investigation of action level excursions.

Speaker
Roger Cowan

Roger Cowan

Pharmaceutical Consultant, R Cowan Consulting Services LLC
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