About the Course
The control of microorganisms in our manufacturing processes and environments is one of the most important tasks in ensuring products are safe and effective. This is true for conventional pharmaceuticals, biotech products, compounding pharmacy drugs, gene and cell therapy products and radiopharmaceuticals. However, conventional microbiology methods are antiquated and do not support the need for faster, accurate and reproducible results. Therefore, the modern laboratory should develop innovative approaches for the detection, quantification and identification of microorganisms using alternative and rapid microbiological methods (RMM).
This comprehensive training course is designed to provide an intensive review of currently available RMM technologies, validation strategies, applications for use, global regulatory views and validation expectations, financial justification models, and technology identification and implementation plans.
The most recent guidance documents on how to validate RMMs, including PDA Technical Report No. 33, USP chapter 1223 and Ph. Eur. chapter 5.1.6 will be discussed in great detail. Additionally, strategies on how to use statistical methods when comparing a new RMM with the compendia method will also be presented, as this is now a regulatory expectation when a firm is seeking approval to use the new method. Case studies on meeting validation and equivalency criteria will also be presented, including a step by step strategy for evaluating the qualitative and quantitative data from validation studies.
Taught by one of the industry’s global leaders in rapid methods, the attendee will be immersed in discussions that will provide a meaningful and understandable roadmap for how to evaluate RMMs and employ them in their own laboratory and manufacturing areas.
Who should attend
Senior management and laboratory personnel responsible for the conduct of microbiological testing and microbial control strategies in manufacturing and product/process development
Microbiology, Quality Control, Quality Assurance, Manufacturing, Validation, Regulatory Affairs, R&D, Discovery, Finance
Directors, Managers/Supervisors, Scientists, Technicians, Operators, Auditors
Benefits to the ParticipantsUpon completion of this course, participants will be knowledgeable in RMM technologies and will be able to develop their own qualification and implementation plans for a variety of microbiology applications.
Issues to be covered
· 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
· Applications for RMMs in bioprocessing and fill finish facilities
· Understanding how to match the right RMM with the intended application, sample matrix and required time to result
· 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
· Cellular-component-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 amplification 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
· Comprehensive and intensive review of validation strategies, including initial due diligence activities, including vendor expectations
· Validation guidance from PDA Technical Report No. 33 and the most up-to-date versions of USP <1223> and Ph. Eur. 5.1.6
· Insights on how to develop a meaningful DQ, IQ, OQ and PQ strategy
· Understand the expectations for primary validation studies using a relevant panel of microorganisms, equivalence testing against the current method and method suitability studies for the test sample or product
· Software and hardware qualification
· Setting acceptance criteria
· Comprehensive review of statistical models with RMM validation case studies
· The role of ICH Q8, Q9 and the process analytical technology initiative (PAT)
· US FDA, EMA, Australian TGA, Japanese PMDA, WHO and Rest of World expectations
· Submission strategies, FDA comparability protocols and research exemptions
· EU variations regulations and using the post-approval change management protocol
· Changing acceptance levels and specifications
· New expectations for using RMMs to test and release gene and cell therapy products and biologics, including allowable sample sizes and required time to result. Review FDA policy changes, Ph. Eur. and USP recommendations for rapid sterility testing.
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
About The Lecturer
Dr. Michael J. Miller
Dr. Michael Miller is an internationally recognized microbiologist and subject matter expert in the due diligence, validation, registration and implementation of rapid microbiological methods, pharmaceutical microbiology, Process Analytical Technology (PAT) and isolator design and qualification. Currently, Dr. Miller is the President of Microbiology Consultants, LLC (http://microbiologyconsultants.com).