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ID#
58
: Justifying Rapid Methods / Student Night
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Date: |
6/16/2009
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Location: |
The Desmond Hotel and Conference Center
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Cost: |
$65
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Who Should Attend:
o Production Management
o Quality Assurance
o Research Microbiologists
o Production Microbiologists
o Pilot Plant / Scaleup Staff
o Compliance / RA Staff
Is your organization considering Rapid Micribiological Methods? Are you and your colleagues interested in the costs to develop and use these methods? Are you challenged with building the business case for the cost of rapid method development and deployment?
Well, we are, and we've invited a subject matter expert, as well as an engaging lecturer, to help refresh our understanding of the subject.
Dr. Michael J. Miller's lecture will be a discussion of the development of rapid methods from a business and cost justification standpoint. He will describe the development costs and the significant operational savings provided by rapid methods.
Dr. Miller will gladly accept questions from the attendees.
LECTURER:
Dr. Michael J. Miller
President, Microbiology Consultants, LLC
TITLE
Breaking the Rapid Microbiological Method Financial Barrier: A Case Study in RMM Return on Investment and Economic Justification
ABSTRACT
The introduction of new rapid microbiological methods (RMMs) has been increasing for a number of years; however, there is a continued hesitancy within the pharmaceutical industry with respect to implementation. If concerns and questions regarding validation strategies and regulatory acceptance have, for the most part, been answered through PDA and compendial guidance, as well as during presentations and discussions with the FDA and EMEA, then there must be another reason why the implementation of RMMs hasn’t progressed. In speaking with manufacturing site heads and production managers, one thing is clear: they want to be convinced that the return on investment, or ROI, is sufficient enough to economically justify the time and expense for qualifying and implementing RMMs for routine use in their facilities. Here lies the problem: there has been little guidance on how to apply financial cost saving models for RMMs, until now.
This presentation will explore not only the technical and business benefits for implementing RMMs, but will provide a comprehensive understanding of where a firm may realize significant cost savings when replacing existing conventional microbiological assays with rapid alternative methods. A brief review of ROI and payback period financial models will be discussed followed by an in-depth case study on how to use these models to economically justify the implementation of an environmental monitoring RMM within an aseptic manufacturing facility. Attendees can then use these same models to develop financial models for the qualification and implementation of any RMM within their own facilities.
BIO
Dr. Michael J. Miller is an internationally recognized microbiologist and subject matter expert in pharmaceutical microbiology, Process Analytical Technology (PAT), isolator design and qualification, and the due diligence, validation, registration and implementation of rapid microbiological methods. 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 and biopharmaceutical 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.
Dr. Miller has authored over 90 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.
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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Featuring: Dr. Michael J. Miller, President |
| Begin Time |
End Time |
Segment Description |
| 5:00 PM |
6:00 PM |
Networking and Cocktail Hour |
| 6:00 PM |
7:30 PM |
Buffet Dinner |
| 7:30 PM |
9:00 PM |
Lecture |
Seating at the meeting is limited and menu selections are firm, so it is necessary for you to register to attend by the close of business on the FRIDAY preceding the meeting. Meals are ordered in advance so we can accommodate NO WALK-IN ATTENDEES. Refunds are not available, but substitutions are always welcome, so register early!
Cost for the meeting is $65.00 per person. (We occasionally have seating available after the pre-registration deadline, and last-minute orders may be accepted at $85.00 / person.) All registrations are done via the PDADelVal web site, and we accept credit cards through the site for payment.
If you plan to pay by company or personal check, click the "pay by check" option on the registration page, print two copies of your registration receipt, and either mail us your payment, or bring it to the meeting, including one of your receipt copies. One of our officers will sign the receipt for you.
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