Rapid Microbiological Methods - RMM

Early Registration Discount
Early registration until May 27, 2018
3,655 NIS + VAT
Registration from May 28, 2018
4,300 NIS + VAT
Lecturer: Dr. Michael Miller

Date: 27, 28 June 2018
Location: Kfar Maccabiah, Ramat Gan
General Information
Duration: 2 - Day Course
Hours: 9:00- 17:00
Price: 4,300 NIS + VAT
Credit Points: 2
SKU: 18343
Course Language: English
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

Rapid Microbiological Methods - RMM
Benefits to the Participants
TBA
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Issues to be covered
Upon 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

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
  • Applications and implementation strategies
  • Understanding how to match the right RMM with the intended application

REGULATORY PERSPECTIVES
  • US FDA, EMA, Australian TGA, Japanese PMDA, WHO and rest of World expectations
  • EU variations regulations and the new post-approval change management protocol
  • Submission strategies, comparability protocols and research exemptions
  • The role of ICH Q8, Q9 and the process analytical technology initiative (PAT)
  • Changing acceptance levels and specifications

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 laser excitation 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, intrinsic fluorescence, Raman 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
  • Comprehensive and intensive review of validation strategies, including initial due diligence activities
  • End user vs. supplier requirements
  • Vendor expectations and audits
  • Insights on how to develop a meaningful DQ, IQ, OQ and PQ program
  • Software and hardware qualification
  • Validation criteria for quantitative, qualitative and identification methods
  • Review and comparison of all sections in the recently revised Ph. Eur. 5.1.6, USP 1223 and PDA Technical Report No. 33
  • Acceptance criteria and the use of equivalence and non-inferiority statistical models, supported by case studies using actual microbiological data and Minicab 17 software analyses
  • Technology transfer

DEVELOPING A BUSINESS CASE
  • 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).
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