Category: Pharmaceutical/Biologics , Bioforum International , Biotechnology , Medical services / Hospitals / Sick Funds , Quality
Rapid Microbiological Methods - RMM
Lecturer: Dr. Michael Miller
Date: 30 April, 1 May 2012
Location:  Kfar Maccabiah, Ramat Gan
Course Language: English
Duration: 2 - Day Course
Hours: 09:00 – 17:00
Registration: 8:30
Price: 4,300 NIS + VAT
Credit Points: 1
SKU: 12343
 
 
Effective monitoring of our manufacturing processes can help to ensure that a state of control is maintained, areas for continual improvement are identified, process and product understanding is enhanced, and manufacturing agility and efficiencies are realized. From a microbiology perspective, we can design processes to prevent contamination, investigate ways to correct a contamination event, and assess the potential impact of failing results on the patient. Unfortunately, our microbiology procedures are trapped in the 19th Century, using conventional methods that have not changed since the discovery of the agar plate!  Therefore, the modern microbiological laboratory should look toward developing innovative approaches to the detection, quantification and identification of microorganisms in our products, processes and manufacturing environments, and recent advances in rapid microbiological methods (RMMs) now provide the analytical tools necessary to accomplish these tasks.

This comprehensive 2-day course is designed to provide an in-depth review of currently available rapid microbiological method (RMM) technologies, validation strategies, applications, regulatory expectations, financial justification models and implementation plans.  Taught by one of the industry’s global leaders in rapid methods, the attendee will be immersed in discussions that will provide a meaningful and understandable roadmap for how to evaluate RMMs and employ them in their own laboratory and manufacturing areas.   
Learning Objectives
Upon completion of this course, participants will be knowledgeable in RMM technologies and will be able to develop their own qualification and implementation plans for a variety of microbiology applications.
Issues to be covered
Introduction
  • History of microbiology methods and the need for change
  • RMM technical benefits as compared with traditional methods
  • Opportunities for use and areas of application including microbial detection, quantification and identification
  • Understanding of how to match the right RMM with the intended application
Technology Review
  • Growth-based technologies that rely on the measurement of biochemical or physiological parameters that reflect the replication and proliferation of microorganisms
  • Viability-based systems that utilize viability stains and/or cellular markers for the detection and quantification of microorganisms without the need for cellular growth
  • Artifact-based technologies that rely on the analysis of cellular components or the use of probes that are specific for microbial target sites of interest
  • Nucleic acid RMMs including PCR-DNA amplification, RNA-based transcription-mediated amplification, 16S rRNA typing and gene sequencing
  • Spectroscopic methods that use of light scattering and other optical techniques to detect, enumerate and identify microorganisms
  • Introduction to Micro-Electro-Mechanical Systems (MEMS), such as microarrays, biosensors and Lab-On-A-Chip technologies
Validation Strategies
  • Guidance from USP <1223>, Ph. Eur. 5.1.6 and PDA Technical Report #33
  • Insights on how to develop a meaningful DQ, IQ, OQ and PQ program
  • Software and hardware qualification
  • Validation and acceptance criteria
  • Use of statistics
  • Vendor expectations
Regulatory Perspectives
  • US FDA expectations
  • EMEA expectations
  • Submission strategies
  • Comparability protocols
  • Research exemptions
  • Changing acceptance levels and specifications
  • The role of process analytical technology initiatives (PAT)
Developing a Business Case for RMMs
  • The need for creating a business case to economically justify RMM implementation
  • Understand how to develop return on investment (ROI) and payback period models
  • Review an actual RMM ROI case study
Review of RMM References
  • Regulatory
  • Pharmacopoeia
  • Journals and books
  • Professional meetings
  • Online references
Who should attend
  • Senior management and laboratory personnel responsible for the conduct of microbiological testing and microbial control strategies in manufacturing and product/process development
  • Microbiology, Quality Control, Quality Assurance, Manufacturing, Validation, Regulatory Affairs, R&D, Discovery, Finance
  • Directors, Managers/Supervisors, Scientists, Technicians, Operators, Auditors
About the Speaker
Dr. Michael J. Miller is an internationally recognized microbiologist and subject matter expert in the due diligence, validation, registration and implementation of rapid microbiological methods, pharmaceutical microbiology, Process Analytical Technology (PAT) and isolator design and qualification. Currently, Dr. Miller is the President of Microbiology Consultants, LLC (http://microbiologyconsultants.com). In this position, he is responsible for providing microbiology, regulatory and quality solutions for the pharmaceutical, biopharmaceutical and medical device industries.

Over the past 20 years, Dr. Miller 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. He has authored over 10 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. Dr. Miller 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. 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, and has served as an adjunct professor at GSU and the University of Waterloo, School of Optometry. Recently, 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).
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