The New Annex 1 Revision And The Impact on Using Rapid Methods For Environmental Monitoring

02nd September 2020 | 10:00am EST | Dr. Michael J. Miller, President of Microbiology Consultants, LLC |WATCH FOR FREE

EU Annex 1 is getting a tremendous makeover and significant revisions enabling the use of rapid methods and changing acceptance levels for environmental monitoring are forthcoming. In this webinar, Dr. Michael J. Miller will present an overview of regulatory and compendial policy changes that encourage the use of rapid methods for environmental monitoring, with a focus on the revision to Annex 1. This will be followed by an actual case study in the use of a real-time rapid method for the instantaneous and continuous detection of microorganisms in an isolator environment.

Presented by Dr. Michael J. Miller, President of Microbiology Consultants, LLC

Dr. Michael J. Miller is an internationally recognized microbiologist and subject matter expert in pharmaceutical microbiology, contamination control and the validation and implementation of rapid microbiological methods (RMM). He is currently the President of Microbiology Consultants, LLC ( and owner of, an educational website dedicated to the advancement of rapid microbiological methods within a variety of healthcare, pharmaceutical, consumer and related industry sectors.

For 30 years, he has held numerous R&D, manufacturing, quality, business development and executive leadership roles at Johnson & Johnson, Eli Lilly and Company and Bausch & Lomb. In his current role, Dr. Miller consults with multinational companies in providing technical, quality, regulatory and training solutions in support of rapid methods, sterile and non-sterile pharmaceutical manufacturing, contamination control and remdiation, environmental monitoring, sterilization and laboratory operations.

Dr. Miller has authored more than 100 technical publications and presentations and is the editor of PDA’s Encyclopedia of Rapid Microbiological Methods. He currently serves on the editorial and scientific review boards for American Pharmaceutical Review, European Pharmaceutical Review and the PDA Journal of Science and Technology. Dr, Miller also was the chairperson during the revision of PDA Technical Report #33: Evaluation, Validation and Implementation of New Microbiological Testing Methods. He currently serves as an advisor to the USP Microbiology Expert Committee in the area of rapid sterility testing.

Dr. Miller holds a Ph.D. in Microbiology and Biochemistry from Georgia State University (GSU), a B.A. in Anthropology and Sociology from Hobart College.

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