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Fireside Chat: Environmental Monitoring – Current Regulatory Thinking – FREE Online
décembre 1, 2021 @ 11:00 - 12:30
This is event is a FREE and LIVE on Dec. 1, 2021 !
Current regulatory thinking about environmental monitoring as outlined in the 2020 Draft of EU Annex 1 focuses on risk assessment across all the key elements of the program. This includes understanding airflows to select risk-based sampling sites, criteria for monitoring equipment, level of microbial identification and mainly understanding trends to evaluate facility condition, personnel practices, predominance of microorganisms; all in an effort to save product from contamination and patient from harm.
Additionally with emerging and reemerging infections and the direction of regulators per FDA’s draft guidance for non-sterile products it is beneficial to evaluate environmental monitoring practices for non-sterile facilities. Risk based monitoring and thorough evaluation of cleanroom flora and trends will help in protecting the non-sterile products form ingress of objectionable microorganisms.
Join industry leaders Ziva Abraham and Parsa Famili for a fireside conversation as they share war stories of their experience transforming environmental monitoring programs in some of Life Science’s most influential companies. Grab a cup of coffee and sit down to listen to their frank dialog about FDA’s draft guidance on Microbiological Quality Considerations in Non-sterile Drug Manufacturing, and EU GMP Annex 1 Revision: Manufacture of Sterile Medicinal Products (Draft,) and the future of environmental monitoring in sterile and non-sterile manufacturing.
Leading Industry Subject Matter Experts on Environmental Monitoring Best Practices:
- Ziva Abraham, CEO, Microrite, Inc.
- Parsa Famili, MSc, President & CEO, NOVATEK INTERNATIONAL