The development of a meaningful strategy for the implementation of rapid microbiological methods requires a certain level of knowledge, skills and competencies on the subject, including the scientific, regulatory and business expectations when assessing and validating RMM technologies. We can provide in-house, world-class professional training and consulting by a world-class technology leader and subject matter expert on RMMs. An overview of our RMM consulting and training services is provided below.
Are you considering implementing rapid micro methods but don't have the in-house expertise to champion these efforts? Are you designing a new RMM technology and want to develop a robust strategy for commercialization? Concerned about regulatory impact and return on investment? Our RMM expert can provide guidance and support in all of these areas, whether you are a supplier of new microbiology technologies or an end-user.
Dr. Miller teams with RMM customers to coordinate the initial assessment of rapid micro methods, recommends the best technology, 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 approval for RMM implementation. Dr. Miller provides an in-depth understanding of FDA and EMEA regulatory expectations for RMM validation and implementation, and can act as your liaison when meeting with regulatory agencies and competent authorities.
Working directly with RMM innovators, start-up companies and global RMM suppliers, Dr. Miller provides technical, regulatory, marketing, sales, business and strategic direction during the design and commercialization of next generation microbiology technologies.
Venture Capital firms interested in early-stage, high-potential companies often look toward experts with technology backgrounds, business training and deep industry experience to help guide them in understanding the long-term potential for their investments. Dr. Miller has experience in assisting a number of VC firms in providing commercialization, strategic and technical direction when considering investing in rapid microbiology opportunities.
Companies find that in-house training is the most cost-effective means to improve the skills and capabilities of their employees. Our RMM trainer, Dr. Miller J. Miller, is an internationally recognized expert in the due diligence, validation, registration and implementation of rapid microbiological methods. He is the editor of PDA's Encyclopedia of Rapid Microbiological Methods, is Chairing the task force responsible for revising PDA's Technical Report #33: Evaluation, Validation and Implementation of New Microbiological Testing Methods, and has been a renowned speaker at numerous RMM conferences around the world.
A comprehensive, intensive and interactive two-day, one-day or half-day training course can be tailored to your company's needs. An example two-day syllabus is provided below:
Rapidmicromethods.com provides a comprehensive introduction to rapid micro methods for the pharmaceutical, biopharmaceutical and other industries, validation guidance, regulatory perspectives, return on investment strategies and technology scientific tutorials. Additionally, the site hosts a comparative rapid method product matrix, blog, calendar of events, newsletter, and an extensive reference page for rapid method publications and white papers that are either in print or available online.