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Rapid microbiological methods have the potential for removing one of the primary bottlenecks in finished product testing, but the methods must be shown to be "equivalent" to the previously approved method. This presentation will look at different methods to validate the alternate method.
The validation, implementation and approval of rapid and alternative microbiological methods has been steadily increasing within the pharmaceutical, biopharmaceutical, compounding pharmacy, and advanced therapy medicinal products (ATMP, gene and cell therapy) industries. Novel drug products and innovative manufacturing processes now require modern strategies for demonstrating microbiological control.
This workshop will provide attendees with an overview of the current landscape for rapid method validation strategies, implementation opportunities, and global regulatory approval processes. Presentations by subject matter experts and global regulators will focus on real-world practices for rapid and alternative microbiology testing of in-process samples and sterile and nonsterile finished product.
This Workshop will present practical approaches to rapid microbiology testing that participants can use in daily work, laboratory, and manufacturing operations.
Module 1- Global Regulatory Overview of Challenges and Opportunities
Description - The implementation of rapid microbiological methods has been gaining momentum across a number of industry sectors. Simultaneously, recent global regulatory policy updates and guidance documents have supported the use of rapid methods. This session will explore current regulatory framework for the validation, submission and utilization of rapid methods. Experts who have worked in this space from the U.S. FDA and EMA will share their experiences and provide additional guidance on how to satisfy regulatory expectations
· Alternative Microbiological Methods Used at Compounding Facilities
· Do the EU GMPs Require the Use of Rapid Microbiological Methods?
Module 2- Regulatory Considerations for Validation and Real-Time Testing
Real-time test results can lead to better decisions regarding the microbiological quality of a product. In some cases, it may provide the only opportunity for testing. In this session, we will explore this burgeoning sub-field of alternative testing methods. This session will also direct participants to useful updates, examples, and resources
· The Evolution Position of the USP on Rapid Microbial Methods
· Alternative Methods for Control of Microbiological Quality
· Development of Rapid Microbiological Methods for the Pharmaceutical Sciences
Module 3 - Rapid Microbial Methods Appropriate for Air and Water Monitoring and Cellular Therapy Sterility Testing
Description: Two case histories are presented how two different organizations approached the selection, validation, regulatory approval, and implementation of the RMM to: 1) improve in-process control in their facility and 2) expedited the detection of microbial contamination in cell cultures. The speakers will highlight lessons learnt during this process.
· Bioflorescent Particle Counter-Based Real-Time Feedback and Control Processing Conditions
· Validation Process for a Rapid Sterility Testing Method to Determine the Sterility of anAdvanced Therapy Medicinal Product (ATMP)
Module 4: Finish Product Testing of Sterile and Non-Sterile Products
Description - Due to increasing demands for expedited product shipments, lean manufacturing processes, and cost reduction efforts, the need for rapid methods for final product testing has become a necessity for expedited testing and product release. This need can be met with rapid microbiology methods. In this session, rapid microbiology methods that have been successfully validated and implemented for both sterile and non-sterile final product testing will be explored.
· Validation of ScanRDI for Release of Compounded Pharmaceutical Products
· Real-Time PCR Detection of Burkholderia cepacia in Pharmaceutical ProductsContaminated with Low Levels of Bacterial Contamination
Module – 5 -- Implementation of Rapid Methods for In-Process and Finished Product Testing
Description - The use of rapid methods for in-process and finished product testing has a number of advantages over conventional testing, including faster times to result that can facilitate GMP decisions related to microbiological control. This session will explore the routine use of rapid Mycoplasma and automated, growth-based technologies and provide a framework for regulatory acceptance and approval for these alternative methods.
· Rapid Mycoplasma Development and Validation Strategy to Obtain Regulatory Approval for MACI® Product Release Testing
· Automated Colony Counting at Biogen: TRP Microbiology Current State of Implementation and Vision
· Validation and Global Implementation of PCR-Based Alternative Mycoplasma-Detection Assays
Chris DeVany is the founder and president of Pinnacle Performance Improvement Worldwide, a firm which focuses on management and organization development. Pinnacle’s clients include global organizations such as Visa International, Cadence Design Systems, Coca Cola, Sprint, Microsoft, Aviva Insurance, Schlumberger and over 500 other organizations in 22 countries. He also has consulted to government agencies from the United States, the Royal Government of Saudi Arabia, Canada, Cayman Islands and the United Kingdom.
He has published numerous articles in the fields of surviving mergers and acquisitions, surviving change, project management, management, sales, team-building, leadership, ethics, customer service, diversity and work-life balance, in publications ranging from ASTD/Performance In Practice to Customer Service Management. His book, “90 Days to a High-Performance Team”, published by McGraw Hill has helped help executives, managers and team leaders improve performance. Mr DeVany has also been interviewed for various radio and television programs.
He has appeared hundreds of times on radio and television interview programs to discuss mergers and acquisitions (how to manage and survive them), project management, sales, customer service, effective workplace communication, management, handling rapid personal and organizational change and other topical business issues. He has served or is currently serving as a board member of the International Association of Facilitators, Sales and Marketing Executives International, American Management Association, American Society of Training and Development, Institute of Management Consultants, American Society of Association Executives, Meeting Professionals International and National Speakers Association. Chris is an award-winning Toastmaster’s International Competition speaker. He recently participated in the Fortune 500 Annual Management Forum as a speaker, panelist and seminar leader.
Chris has distinguished himself professionally by serving multiple corporations as manager and trainer of sales, operations, project management, IT, customer service and marketing professionals. Included among those business leaders are Prudential Insurance, Sprint, BayBank (now part of Bank of America), US Health Care and Marriott Corporation. He has assisted these organizations in mergers and acquisitions, facilitating post-merger and acquisition integration, developing project management, sales, customer service and marketing strategies, organizing inbound and outbound call center programs, training and development of management and new hires, and fostering corporate growth through creative change and innovation initiatives.
Chris holds degrees in management studies and organizational behavior from Boston University. He has traveled to 22 countries and 47 states in the course of his career.