Rapid Microbiological Methods Master Class
This intensive TWO (2) DAY online training course provides the most comprehensive overview on how to select, validate and implement rapid microbiological methods (RMM) for the pharmaceutical, cell therapy, pharmacy compounding and related healthcare industries. Taught by the world's leading subject mater expert in RMMs, you will be immersed in practical discussions with the most up-to-date industry best practices and regulatory expectations.
Dates: Wednesday & Thursday, April 1-2, 2020
Time (both days): 10:00 AM EDT - 2:30 PM EDT (U.S. East Coast Time)
Early Registration By March 1: $999.00 USD PER PERSON
Regular Registration After March 1: $1,199.00 USD PER PERSON
NOTE: A separate registration fee is required for EACH PERSON even if they are logging in from the same location. Please review our cancellation and refund policy below.
Online Master Class Benefits
NO Travel Costs
NO Extended Time Away from the Office
REDUCED PRICE Compared with On-Site Training Programs (e.g., up to $1,000 savings per person)
PDF of Course Material
Master Class Agenda
Wednesday, April 1, 2020
10:00 AM EDT - Introduction
- History of microbiology methods and the need for alternative and rapid technologies
- RMM benefits when compared with traditional microbiology methods
- Applications for microbial detection, quantitation and identification
- Understanding how to match the right RMM with the intended application and test samples
10:15 AM EDT - Regulatory Perspectives
- Current policies and expectations from the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Australian Therapeutic Goods Administration (TGA), the Japanese Pharmaceutical and Medical Devices Agency (PMDA) and the World Health Organisation (WHO)
- Considerations for other Rest of World regulators
- Submission strategies, FDA comparability protocols and research exemptions, EMA Type Variations and the Post-Approval Change Management Protocol
- The regulatory impact of changing acceptance levels and in-process or finished product specifications
11:00 AM EDT - New Regulatory Policies for Rapid Sterility Testing of ATMPs (gene and cell therapies)
- Understand the limitations of the compendial sterility test for cell therapy products
- Discuss acceptable sampling strategies when the compendial sample requirements cannot be met
- Review Ph. Eur. 2.6.27, Microbiological Examination of Cell-Based Preparations and its impact on how these products should be evaluated for sterility
- Discuss 21 CFR 610.12, Sterility Test and its impact on cell therapy products
- Understand recent FDA and EU policy changes regarding sterility testing of ATMPs and the use of rapid methods
- Review guidance from new compendial chapters including USP <1071>, Rapid Microbial Tests for Release of Sterile Short-Life Products: A Risk-Based Approach
- Case studies on selecting sample sizes to meet regulatory and compendial expectations.
12:00 PM EDT - 15-MINUTE BREAK
- Please stay connected during this time.
12:15 PM EDT - Technology Reviews
- 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-based technologies that rely on the detection of microbial components or the use of probes that are specific for microbial target sites of interest
- Spectroscopic methods that use of light scattering and other optical techniques to detect, enumerate and identify microorganisms
- Nucleic acid RMMs including PCR-DNA amplification, RNA-based transcription-mediated amplification, 16S rRNA typing and gene sequencing
- Introduction to Micro-Electro-Mechanical Systems (MEMS), such as microarrays, biosensors and Lab-On-A-Chip technologies
2:30 PM EDT - Final Q&A - End of Day 1
Thursday, April 2, 2020
10:00 AM EDT - Validation Strategies
- How to develop a validation strategy that meets regulatory expectations
- Risk analysis
- User Requirements Specifications (URS), Functional Design Specifications (FDS), Requirements Traceability Matrix (RTM)
- Supplier assessments and audits
- Developing the test plan, including installation, operational and performance qualifications (IQ, OQ and PQ)
- Method validation and suitability testing
- How to test validation criteria, such as Accuracy, Precision, Limit of Detection, Specificity and Equivalence
- Use of stressed organisms and environmental isolates
- How to perform statistical analyses
- Technology transfer, site commissioning and implementation
- Comparisons of the current validation guidance documents, including PDA Technical Report #33, USP <1223> and Ph. Eur. 5.1.6
12:00 PM EDT - 15-MINUTE BREAK
- Please stay connected during this time.
12:15 PM EDT - Continuation of Validation Strategies
2:10 PM EDT - 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 on a real-time RMM
2:30 PM EDT - Final Q&A - End of Day 2
Master Class Times
- All times are in Eastern Daylight Time (EDT; U.S. East Coast Time). Please visit the World Clock to confirm your local time..
- Start and stop times are estimates and may change based on attendee questions.
Payments, Refunds & Cancellations
Payment for each participant must be received at least 24 hours prior to the Master Class start date and time. Refunds will not be provided to registrants who do not attend the live event. If a refund request is received by March 18, 2020, a refund will be provided minus a $200.00 processing fee. After March 18, 2020, no refunds will be provided. In the event of a cancellation by the Master Class organizer due to lack of enrollment or other unavoidable reasons, registrants will be provided a full refund.
Computer and Call-In Requirements
You are required to utilize a desktop computer or handheld device to view the class material. Registrants are responsible for ensuring that their computer or handheld device is compatible with GoToWebinar at least one day prior to the start of the webinar. We strongly recommend you click on the following link to perform a system compatibility check:
Please login at least 30 minutes prior to the start of the Master Class to ensure that you are properly connected. If you experience difficulties, please call us at +1 72743 72743 or email us at email@example.com so that we can assist you getting online. NOTE: we are unable to provide assistance once the Master Class begins.
You may listen to the audio portion of the Master Class when you login with your computer or handheld device, or by calling in via telephone. Call-in numbers for multiple countries will be provided when your registration is confirmed.
Master Class Course Material
A link to download a PDF of the course material will be provided to each participant prior to the start of the Master Class. The course material is copyright protected and is being provided for your personal use only. The contents of the PDF (whether in its entirety or parts thereof) must not be copied, distributed or published.
Dr. Michael J. Miller is an internationally recognized microbiologist and subject matter expert in pharmaceutical microbiology and the design, validation and implementation of rapid microbiological methods. He is currently the President of Microbiology Consultants, LLC (http://microbiologyconsultants.com). For more than 30 years, he has held numerous R&D, manufacturing, quality and business development leadership roles at Johnson & Johnson, Eli Lilly and Company, Bausch & Lomb, and Pharmaceutical Systems, Inc. In his current role, Dr. Miller consults with multinational companies in providing technical, quality and regulatory support for rapid methods, sterile and non-sterile pharmaceutical manufacturing, ATMPs, contamination control and investigations, and GMP compliance.
Dr. Miller holds a Ph.D. in Microbiology and Biochemistry from Georgia State University and a B.A. in Anthropology and Sociology from Hobart College. He has authored more than 100 technical publications and presentations and was the editor of PDA’s Encyclopedia of Rapid Microbiological Methods. He currently serves on the editorial and review boards for European Pharmaceutical Review, American Pharmaceutical Review and PDA Journal of Science and Technology. He is also the chairperson for the 2020 revision of PDA Technical Report #33.