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Water Webinar

Overview

Title: Real-Time Process Control for Healthy, High-Purity Water Systems

Date: Thursday, March 15, 2018

Time: 11:00 AM Eastern Daylight Time

Duration: 1 hour

Summary

Current water testing methods pose a risk to products because, oftentimes, the results are not available at the time the water is used. This webcast will discuss current regulations and the implementation of a new class of instrumentation, online water bioburden analyzers (OWBAs), on high-purity water systems for the purpose of gaining a more meaningful view of water system health through the use of real-time process control techniques.

Experts will review a case study that illustrates how to use online bioburden data—in concert with data from other sensors on a water loop—to construct a holistic assessment, drive decision-making, and result in a more cost-effective water management system strategy.  Participants will come away with a roadmap for ensuring optimal water system operation, including how to structure a robust system monitoring practice that provides the foundation for future system optimization.

The webcast will include guidance on:

  • Using real-time, continuous bioburden data to connect and augment sensor information already present on a high purity water loop to gain a more informed and actionable view of water system health.
  • Implementing a tool that can be used to develop predictive models and extend beyond the basic trending supported by standard data historians and off-line data analysis.

 

Allison Scott, Ph.D.
Senior Applications Engineer
Azbil North America Research and Development, Inc.

Dr. Allison Scott is a senior applications engineer specializing in the BioVigilant IMD product line at Azbil North America Research and Development, Environmental Particle Solutions. She has been a member of the Azbil BioVigilant team since 2010, where a majority of her work has focused on the evaluation of the company’s rapid microbial detection technology, its diverse applications in air and water monitoring, and in supporting end users in its implementation. She is actively involved in the on-going development and execution of a variety of biologic challenge and interferent test protocols to assess system efficacy and has co-authored a number of technical articles and posters on the subject. She has over four years of additional biologic detector experience gained through work on an infrared-based sensor for use in the detection of microbes in water supplies. She earned her joint doctorate in materials science and engineering from the University of Arizona and in materials chemistry from the University of Rennes.

Lisa Graham, Ph.D., PE
CEO and Founder
Alkemy Innovation, Inc.

Dr. Lisa Graham is CEO and founder of Alkemy Innovation, Inc., an engineering company with a well-developed acumen in crafting data analytics solutions for the pharmaceutical, life science, and related industries. Lisa is a registered professional chemical engineer with 20 years technical and business experience and expertise in chemical engineering, data analytics, ERP system planning, applied mathematics, and process analytical technology applications. Lisa earned a bachelore of science and doctorate in chemical engineering from Oregon State University, and has cultivated her skills serving companies in C-level positions including COO, senior vice-president, CEO, and chief scientist. She is the author of 12 scientific papers and 25 professional presentations, with two patents. She is also actively involved in supporting higher education, specifically STEM education initiatives, and economic development at the state level, including serving as Chair of the Board for Oregon Tech and serving on the Governor’s STEM Investment Council.

Michael J. Miller, Ph.D.
President of Microbiology Consultants, LLC
Owner of RapidMicroMethods.com

Michael J. Miller is an internationally recognized microbiologist and subject matter expert in pharmaceutical microbiology, contamination control, aseptic processing, sterilization, laboratory design, and the validation and implementation of rapid microbiological methods (RMM). For almost 30 years, he has held numerous R&D, manufacturing, quality, business development and executive leadership roles at multinational firms such as 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 RMMs, sterile and non-sterile pharmaceutical manufacturing, contamination control, isolator technology, environmental monitoring, sterilization and antimicrobial effectiveness.

He 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.

Dr. Miller holds a doctorate in microbiology and biochemistry from Georgia State University and a bachelor’s degree in anthropology and sociology from Hobart College.