Welcome to Microbiology Consultants, LLC.
Microbiology Consultants, LLC provides expert microbiology consulting, contamination control, compliance, and training solutions for the pharmaceutical, biotech, medical device and healthcare regulated industries. We utilize a global network of microbiology consultants whose capabilities are focused in Good Manufacturing Practices (GMPs), laboratory operations, microbiology investigations, and the implementation of new technologies for the detection and identification of microbial contaminants. We help our clients create value and architect change through our unique spectrum of regulatory guidance, microbiology consulting and quality risk management approaches, which is key for companies that want to renew their attention to continuous process improvement and operational excellence.
Our Principal Microbiology Consultant
Dr. Michael J. Miller is an internationally recognized microbiology consultant and subject matter expert in pharmaceutical microbiology and cutting-edge rapid microbiological methods and new technologies. He is routinely sought after as a microbiology consulting resource by the industry's most successful pharmaceutical and biotech companies, technology innovators and training organizations from around the world.
Experienced
Dr. Miller has held numerous technical, consulting, management and senior leadership roles within Research and Development, Manufacturing, Quality Assurance and Business Development at renowned companies such as Johnson & Johnson, Eli Lilly and Company and Bausch & Lomb. With more than 22 years of practical industrial experience, and almost 30 years of microbiology expertise, Dr. Miller provides comprehensive, effective and hands-on microbiology consulting solutions for the pharmaceutical, biopharmaceutical, medical device and other regulated industries.
Recognized
Dr. Miller has been recognized by professional organizations and academic institutions. His most recent awards and appointments are as follows:
- 2010. Adjunct Professor. Georgia State University, Atlanta, Georgia
- 2010. Co-chair. PDA Technical Report #33 Task Force
- 2008. John Henry Hobart Fellow in Residence for Ethics and Social Change, Hobart and William Smith Colleges, Geneva, New York
- 2006. Distinguished Service Award, Parenteral Drug Association (PDA)
- 2006. Microbiologist of the Year, Institute for Validation Technology (IVT)
Highly Regarded WIthin the Scientific Community
Dr. Miller has been invited to speak and serve as Chairperson at some of the world's most prestigious microbiology and pharmaceutical science and technology conferences and training events. Most recently, his presentations have focused on rapid microbiological methods, pharmaceutical and biotech microbial control strategies and environmental monitoring. Dr. Miller also routinely publishes on similar topics in peer-reviewed journals, technical books and scientific trade journals, and is the Editor of the PDA Encyclopedia of Rapid Microbiological Methods.
Click here to review a complete list of Dr. Miller's presentations.
Click here to review a complete list of Dr. Miller's publications.
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Microbiology Expert Witness
Dr. Miller has significant education, training, skill sets and experience in pharmaceutical microbiology and contact lens care microbiology, including preservative and disinfection effectiveness testing, and has practical experience as an expert witness in product liability and patent litigation. He is available for legal consultation, deposition and patent review, fact finding, discovery, expert opinion and testimony. Please contact us to discuss Dr. Miller's legal fees and availability.
No Cost Initial Consultation
We want to completely understand what your needs are in order for us to recommend an appropriate microbiology consulting program that will exceed your expectations. Please click here to fill out a brief inquiry form and our principal consultant will contact you directly. Alternatively, you can email, text or call us at your convenience:
Phone or Text: +1 727 437 2743 (RAPID-RAPID) Email: mjm@microbiologyconsultants.com |
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Pharmaceutical Microbiology Consulting Services
Dr. Miller has practical experience in a wide range of pharmaceutical microbiology applications and has access to a network of worldwide microbiology consulting experts. His capabilities include:
- Sterility assurance and aseptic processing
- Environmental monitoring
- Bioprocessing microbial testing and control strategies
- Isolator and RABS cycle development and validation
- Contamination control and investigations
- Pharmacopoeial compliance
- Method development and validation
- Laboratory design and qualification
Click here to learn more about our microbiology consulting capabilities.
Rapid Microbiology Consulting Services
Dr. Miller is a world-wide leader in the development, validation and implementation of rapid microbiology technologies, and has been helping to promote the advancement of RMMs for almost 20 years.
He has a proven track record of rapid microbiology consulting with start-up companies, venture capital firms and global RMM vendors, providing technical, regulatory, marketing, sales, business and strategic expertise during the design and commercialization of next generation microbiology technologies.
Dr. Miller also consults directly with RMM end-users to coordinate the initial assessment of RMM technologies, matches the right technology with the intended application, and creates feasibility and validation test plans, comparability protocols and Quality Expert Reports. He has developed extensive return on investment (ROI) models for rapid micro methods and will work with your senior management and finance groups to gain business approval for RMM implementation. Dr. Miller provides an in-depth understanding of FDA and EMA regulatory expectations for RMM validation, and can act as your liaison when meeting with regulatory agencies and competent authorities.
Rapid Microbiology Training and In-House Courses
As the editor of the PDA Encyclopedia of Rapid Microbiological Methods and a renowned speaker at numerous RMM conferences around the world, Dr. Miller is an excellent resource for providing on-site presentations and full-day training courses on the many facets of rapid micro methods and how these new technologies can be implemented at your facility. Recently, he launched a new website dedicated to the advancement of rapid microbiology.
Click here to learn more about our rapid microbiology consulting capabilities.