December 1st, 2021
11:00 AM – 12:30 PM EDT
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Additionally with emerging and reemerging infections and the direction of regulators per FDA’s draft guidance for non-sterile products it is beneficial to evaluate environmental monitoring practices for non-sterile facilities.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 Grab a cup of coffee and sit down to listen to their frank dialog about FDA’s draft guidance on Microbiological Quality Considerations in Non-sterile Drug Manufacturing, and EU GMP Annex 1 Revision: Manufacture of Sterile Medicinal Products (Draft,)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.