Environmental Monitoring is a requirement as part of aseptic production operations, and especially critical in barrier environments such as Isolators and RABS. Environmental monitoring within an isolator should be based upon a formal risk assessment concerning the product, and process and routes of entry.
In this presentation we will explore:
- Regulatory requirements for environmental monitoring
- How to set up a risk-based sampling plan
- Introduction to innovative and effective technology solutions available to enhance your environmental monitoring program.
Speaker
Anne Connors
Merck
Senior Field Marketing Manager
Anne Connors is a Senior Field Marketing Manager at Merck, specializing in pharmaceutical microbiology applications. Anne’s areas of expertise are in Environmental Monitoring, Pyrogen, and Sterility testing, as well as pharmaceutical microbiology regulations. Anne holds a B.S. in Organismal Biology and has over 14 years of industry experience. Previous to her role at Merck, she was a Senior Scientist in QC Microbiology, specializing in validation and method development and as a subject matter expert. Anne is also actively engaged as volunteer faculty and for the PDA.
Pharma and biopharma manufacturing
- Classical pharma manufacturing
期間:48min
言語:English
セッション 1:presented April 26, 2022
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