We Are Going Back to the Future with Rapid Methods.

Rapid methods have been available to the pharmaceutical industry for decades. And although global regulations have changed to encourage their use, especially for rapid sterility testing, and the compendia enhanced their chapters to promote the validation and implementation of these technologies, only a handful of firms have embraced rapid methods to their fullest potential. This presentation, will once and for all disprove the misconceptions and address any confusion surrounding rapid method applications and acceptance. We will also discuss the most current enablers, including guidance from USP, Ph. Eur., Annex 1, FDA and EMA, and share successful case studies where rapid methods have had the greatest impact.
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 (http://microbiologyconsultants.com) and owner of http://rapidmicromethods.com, 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.
Followed by Félix Montero-Julian, Scientific Director at bioMérieux

Félix Montero-Julian is the Scientific Director for the Healthcare Business of bioMérieux (Lyon, France). Felix has over 25 years of experience in industrial and clinical diagnostics, and previously served as the Chemunex Ivry-sur-Seine site & R&D Director in bioMérieux. Felix is a member of different scientific organizations, such as the Parenteral Drug Association (MD, USA), and served as an expert in a panel for the Development of Compendial Rapid Sterility Tests for the US Pharmacopeia (MD, USA). Félix has been, and continues to be, extensively involved in the implementation and acceptance of rapid and alternative microbiological methods. He is a prominent speaker at congresses and conferences and a regular contributor to bioMérieux scientific white papers. Félix has extensive technical experience that includes the development of in vitro diagnostic and research use reagents and applications, cell and tissue culture systems, alternative and rapid microbiological methods, sterility testing, Mycoplasma detection, compendia methods, and cell and gene therapy processes.
Sponsored by BioMérieux

With more than 50 years of pioneering diagnostics, the people of bioMérieux understand the challenges you face when it comes to ensuring product quality and are proud to offer the most comprehensive portfolio of solutions for microbiology Quality Control of biopharmaceuticals and ATMPs.  Choosing the right microbiology diagnostic can boost efficiency with in-processes testing and automation simplifies the testing processes, reduces human error, and helps ensures data integrity. Rapid, simple, at-line testing of key parameters allows in-process tests to be performed closer to the production environment and provides certainty that your manufacturing process is secure.