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WEBINAR: Regulatory Perspectives on Rapid Microbiological Methods

Rapid Micro Biosystems® is proud to partner with industry thought leader Dr. Michael Miller to share his expert perspective on validation and implementation of rapid methods such as the Growth Direct® System.


Topics will include:

  • Global regulations encouraging use of rapid methods
  • Regulatory enablers USP, Ph.Eur., FDA, EMA and their promotional view on implementation automated technologies
  • Regulatory expectations of QC microbiology
  • Annex 1 published revisions

Miller headshot

Dr. Michael J. Miller is an internationally recognized microbiologist and subject matter expert in pharmaceutical microbiology, contamination control and the validation of rapid microbiological methods. He is the President of Microbiology Consultants, LLC and owner of rapidmicromethods.com, an educational website dedicated to the advancement of rapid microbiological methods. For more than 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 the areas of microbiology, quality and regulatory affairs in support of rapid methods, sterile and non-sterile pharmaceutical manufacturing and contamination control. Dr. Miller has authored more than 100 technical publications and presentations and currently serves on the editorial and scientific review boards for American Pharmaceutical Review, European Pharmaceutical Review and the PDA Journal. Dr, Miller is the chairperson for the current revision of PDA Technical Report #33: and has served 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.