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Environmental Monitoring in Aseptic Operation
Environmental Monitoring in Aseptic Operation
Environmental Monitoring in Aseptic Operation
This session covered solutions in aseptic processing in which you can apply. Identify what is happening in the world of sterile technologies, implications of warning letters, review case studies, explain regulatory trends, and expand your industry know-how. At the conclusion of this course, participants will be able to:
  • Why aseptic processing is on of the most important manufacturing controls
  • Understand that the presence of mircoorganisms can impact product process quality
  • Understand how the use of quality risk management principles can be used to monitor and control the manufacturing environment

  • Speaker Biography
    Michael J. Miller, Ph.D. is an internationally recognized microbiologist and subject matter expert in pharmaceutical microbiology and the design, validation and implementation of rapid microbiological methods. He is currently the President of Microbiology Consultants, LLC. In this role, he is responsible for providing scientific, quality, regulatory and business solutions for the pharmaceutical industry and suppliers of new microbiology technologies. Over the past twenty-one years, he has held numerous R&D, manufacturing, quality, consulting and business development leadership roles at Johnson & Johnson, Eli Lilly and Company, Bausch & Lomb, and Pharmaceutical Systems, Inc. Miller has authored over 100 technical publications and presentations in the areas of rapid microbiological methods, PAT, ophthalmics, disinfection and sterilization, and is the editor of PDA's Encyclopedia of Rapid Microbiological Methods. He currently serves on a number of PDA's program and publication committees and advisory boards, and is co-chairing the revision of PDA Technical Report#33: Evaluation, Validation and Implementation of New Microbiological Testing Methods. Miller holds a Ph.D. in microbiology and biochemistry from Georgia State University (GSU), a B.A. in anthropology and sociology from Hobart College, and is currently an adjunct professor at GSU and the University of Waterloo, School of Optometry. He was appointed the John Henry Hobart Fellow in Residence for Ethics and Social Justice, awarded PDA's Distinguished Service Award and was named Microbiologist of the Year by the Institute of Validation Technology (IVT).
    Discounted member price: 49.00
    Your price: 149.00
    You could save 67.1%
    This self-paced, pre-recorded course includes a downloadable presentation for note-taking, engaging graphics, links to regulatory information, assessments to measure your comprehension and the ability to start and stop at any time, beginning where you left off.

    ISPE CEUs are provided once you achieve an 80% passing grade and complete the evaluation as required.

    Approximate Course Duration: 40 minutes (this is a self-paced course)

    *NOTE* You will have 5 calendar days to access and complete this course from time of purchase.

    ISPE CEUs: .08 ISPE CEUs will be awarded upon successful completion of grading requirements

    Member Price: $ 49.00 / € 45.00
    Non Member Price: $ 149.00 / € 136.00
    Item #: WEBTPAAOUS

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