Rapid Microbiology Consulting and Training
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.
Rapid Methods Consulting Opportunities
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.
Consulting with End-Users
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.
- Create a corporate rapid method strategy and communicate to senior management
- Review current conventional methods and identify appropriate RMM technologies as alternatives
- Develop and manage feasibility studies (in-house or with the technology vendor)
- Prepare and support the execution of a comprehensive validation plan, including DQ, IQ, OQ, PQ and equivalency studies that are aligned with USP <1223>, Ph. Eur. 5.1.6 and PDA Technical Report #33
- Formulate regulatory acceptance strategies and discuss with your Regulatory Affairs department
- Establish a relationship with relevant Regulatory Agencies and set up initial strategy meetings
- Develop Return on Investment (ROI) and business justification models
- Compose FDA comparability protocols and EMA Expert Reports
- Construct and deliver a comprehensive and holistic in-house training program
Consulting with Suppliers of RMM Technologies
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
- Conduct due diligence activities for new technologies or potential mergers, acquisitions or investments
- Create industry focus groups and moderate discussions
- Prepare validation plans that are aligned with USP <1223>, Ph. Eur. 5.1.6 and PDA Technical Report #33
- Oversee contract laboratory testing and in-house microbiology studies
- 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
- Consult with your customer base on validation, regulatory and implementation strategies
- Construct and deliver a comprehensive and holistic in-house training program
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.
In-House Rapid Methods Training Course
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:
Introduction
- History of microbiology methods and the need for change
- RMM technical benefits when compared with traditional methods
- Opportunities for use and areas of application including microbial detection, quantification and identification
- Understanding how to match the right RMM with the intended application
Technology Review
- Growth-based technologies that rely on the measurement of biochemical or physiological parameters that reflect the replication and proliferation of microorganisms
- Viability-based systems that utilize viability stains and/or cellular markers for the detection and quantification of microorganisms without the need for cellular growth
- Artifact-based technologies that rely on the analysis of cellular components or the use of probes that are specific for microbial target sites of interest
- Nucleic acid RMMs including PCR-DNA amplification, RNA-based transcription-mediated amplification, 16S rRNA typing and gene sequencing
- Spectroscopic methods that use of light scattering and other optical techniques to detect, enumerate and identify microorganisms
- Introduction to Micro-Electro-Mechanical Systems (MEMS), such as microarrays, biosensors and Lab-On-A-Chip technologies
Validation Strategies
- Guidance from USP <1223>, Ph. Eur. 5.1.6 and PDA Technical Report #33
- Insights on how to develop a meaningful DQ, IQ, OQ and PQ program
- Software and hardware qualification
- Acceptance criteria and the use of statistics
- Vendor expectations and audits
Regulatory Perspectives
- US FDA and EMA expectations
- Submission strategies, comparability protocols and research exemptions
- Changing acceptance levels and specifications
- The role of process analytical technology initiatives (PAT)
Developing a Business Case for RMMs
- The need for creating a business case to economically justify RMM implementation
- Understand how to develop return on investment (ROI) and payback period models
- Review an actual RMM ROI case study
Rapidmicromethods.com
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.