Welcome to Microbiology Consultants, LLC
Microbiology Consultants, LLC provides expert microbiology consulting, contamination control, pharmacopoeia compliance, expert witness and training solutions for the pharmaceutical, biotech, medical device and healthcare regulated industries. We utilize a global network of microbiology consultants and experts 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.
The Industry's Most Talented Microbiology Experts
Microbiology Consultants, LLC partners with a team of pharmaceutical microbiology consultants whose decades of hands-on experience bring the most capable and talented resources to your project. We carefully consider your requirements and match these needs with experts that are proficient, competent and highly respected in their field. Everyone on our team has practical experience in pharmaceutical microbiology, sterile, nonsterile and bulk drug manufacturing, quality assurance, quality control, regulatory affairs and/or GMP compliance.
Our Principal Microbiology Consultant
Dr. Michael J. Miller is an internationally recognized subject matter expert and expert witness in pharmaceutical microbiology, contamination control, GMP's, pharmacopoeia compliance 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.
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 30 years of microbiology experience, Dr. Miller and his team provides comprehensive, effective and meaningful microbiology consulting solutions for the pharmaceutical, biopharmaceutical, medical device and other regulated industries. Dr. Miller's experience, publications, speaking engagements and CV is available for your review.
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Connect with Dr. Miller on LinkedIn |
In-House Training Opportunities
Our network of microbiology experts have provided comprehensive and intensive in-house training courses for multinational companies located around the world. We tailor our training modules to meet your immediate and long-term needs, and engage participants in detailed case studies, practical exercises and thought provoking discussions. Training courses can last as little as a few hours, or as long as a few days, depending on your requirements. Examples of topics we have covered include:
- Basic and advanced pharmaceutical microbiology
- Method validation and pharmacopoeia compliance
- Contamination control
- Environmental monitoring
- Good Manufacturing Practices (GMP)
- Identification of microorganisms
- Microbial data deviations and investigations
- Validation and implementation of rapid microbiological methods (RMM)
Click here to learn more about our microbiology training capabilities.
Pharmaceutical Microbiology Expert Witness
Dr. Miller has significant education, training, skill sets and experience in pharmaceutical microbiology, contamination control, GMPs, sterility assurance, sterilization, preservative effectiveness, environmental monitoring, pharmacopoeia (USP) compliance (including USP 71, sterility testing, and USP 797, pharmaceutical compounding of sterile preparations), product development, manufacturing and contact lens care microbiology. He has practical experience as an expert witness in patent litigation and product liability cases. Dr. Miller has represented branded and generic drug companies, plaintiffs and defendants, and has provided consultation, patent review, fact finding/discovery, expert opinion, deposition and trial testimony. Please Contact Us to discuss Dr. Miller's legal fees and availability.
No Cost Initial Consultation
We would like the opportunity to discuss your contamination control, laboratory start-up, GMP compliance or training needs. 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
Our network of expert microbiologists have practical experience in a wide range of pharmaceutical microbiology areas including:
- Start up of new laboratories and manufacturing facilities
- Contamination control and GMP compliance
- Sterility assurance and aseptic processing
- Sterilization and preservative/disinfection effectiveness
- Fermentation, recovery and purification
- Environmental monitoring
- Microbial identification
- Isolators and RABS: cycle development and validation for manufacturing and sterility testing
- Failure investigations and microbial data deviations
- Pharmacopoeia method suitability, validation and testing
- Regulatory submissions, inspections and audit response
- Laboratory design, start-up and qualification
- GMP auditing of laboratories and manufacturing
- Rapid microbiology method (RMM) development, validation and implementation
- Bioprocessing, small and large molecule manufacturing, sterile and non sterile products
- Compounding pharmacy microbiology, USP 797 and USP 71
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 more than 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.
As the editor of the PDA Encyclopedia of Rapid Microbiological Methods and owner of rapidmicromethods.com , Dr. Miller is also an excellent resource for providing on-site presentations and full-day training courses on the many facets of rapid microbiological methods and how these new technologies can be implemented in your facility.
Click here to learn more about our rapid microbiology consulting and training capabilities.