Our team of consultants possess decades of hands-on, practical experience in pharmaceutical microbiology, sterile, nonsterile and bulk drug manufacturing, quality assurance, quality control, regulatory affairs, GMPs and pharmacopoeia compliance.
Dr. Michael J. Miller is an internationally known subject matter expert in pharmaceutical microbiology and rapid microbiological methods. With 30 years experience in the field, he is retained 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's CV is available for your review.
Dr. Miller has practical experience as an expert witness in patent litigation and product liability cases. He has successfully defended his clients in the areas of pharmaceutical microbiology, contamination control, GMPs, sterility assurance and sterilization, preservative effectiveness, pharmacopoeia (USP) compliance, manufacturing and contact lens care microbiology. Dr. Miller has represented branded and generic drug companies, plaintiffs and defendants, and has been retained for consultation, patent review, discovery, expert opinion, deposition and trial testimony. Please Contact Us to discuss Dr. Miller's legal fees and availability.
Dr. Miller is an expert in the design validation and implementation of rapid and alternative microbiology methods. He has provided technical, regulatory, marketing, sales and strategic guidance to technology suppliers and end-users for many years. Dr. Miller can provide an in-depth understanding of FDA and EMA regulatory expectations for RMM validation, assist with validation protocols and act as your liaison when meeting with regulatory agencies.
As the owner of the educational website rapidmicromethods.com, Dr. Miller is also an excellent resource for providing on-site presentations and full-day training courses on RMMs implementation.
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Phone or Text: +1 727 437 2743 (RAPID-RAPID)
Our network of expert microbiologists have practical experience in a wide range of pharmaceutical microbiology areas including:
Our network of microbiology experts have provided comprehensive in-house training courses for multinational companies 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. Examples of topics we have taught include: