MICROBIOLOGY CONSULTANTS, LLC
LUTZ, FLORIDA

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. Develop Return on Investment (ROI) and business justification models 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. Support the development of strategic, business and commercialization plans Develop regulatory strategies and establish your company with key global Regulatory Agencies Support the development and submission of FDA Drug Master Files (DMF) Develop Return on Investment (ROI) and business justification models that can be used with potential customers Consulting with Venture Capital Firms 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. 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: Submission strategies, comparability protocols and research exemptions Developing a Business Case for RMMs The need for creating a business case to economically justify RMM implementation 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. Microbiology Consultants, LLC. 19009 St. Laurent Drive, Lutz, Florida 33558 USA • Microbiology Consultants, LLC focuses on providing regulatory, quality and compliance solutions for the pharmaceutical, biotech, medical device and other regulated industries. Courses can be scheduled according to your business' day-to-day activities and held in-house, so employees don't need to travel. Contamination control concepts and risks, where microorganisms come from, types of microorganisms that can contaminate pharmaceutical processes and products, general contamination control procedures, regulatory expectations, personnel and material flow issues, environmental concerns Introduction to objectionable organisms and potential pathogens, examples of product quality issues and quality/regulatory concerns Microbiological Control in Pharmaceutical Products and Manufacturing Environments: Strategies and Regulatory Expectations (1 Day) Examples of microbiological failures in environmental monitoring, sterile and nonsterile finished product release testing, and raw material and component analyses Microbiological controls and specifications/limits/levels for raw materials, in-process and finished product Sterility testing, technical and regulatory requirements, antibiotics and preserved products, challenges with dosage forms Cleaning and disinfection expectations, environmental considerations, product contact surfaces, tanks and vessels Outcomes of manufacturing and/or product contamination, regulatory, quality, patient Environmental monitoring failures, investigations, resolution, impact to media fills and finished product Regulatory submissions, audit response and consent decree 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: Business Address and Contact Information Microbiology Consultants, LLC This information will only be used to contact the submitter and will not be provided to third parties.