Validating a rapid method for pharmaceutical applications
Validation of rapid methods continues to be an obstacle to greater adoption of these technologies. Some of the benefits of rapid methods are well articulated across industry literature, including the ability to release products much faster as well as intervene faster in the event of contamination in any part of the manufacturing process. Regulatory approval and the challenge of actually validating the rapid method for many applications continue to be viewed as stumbling blocks.
Silvia Fragoeiro, Team Leader – MSD Animal Health, Merck
Experiences in implementing and validating a rapid method
Silvia Fragoeiro of MSD will be speaking about her experiences with implementing a rapid method. She recently co-authored an article in EPR on the implementation of a rapid method to improve the quality of polyclonal antibodies used for the quality control of antigens produced by MSD for vaccines. She will be speaking about her experiences in implementing and validating a rapid method for this application.
Juan Gonzalez-Garzon, Applications Specialist Industry-Europe, BD
A flow cytometry based rapid method and the various applications that can be performed
Juan has a B.Sc. degree in Pharmaceutical Sciences from the University Complutense in Madrid, specializing in Food Microbiology and Dietetic, with a dedicated internship in the clinical microbiology Laboratory at the Hospital Gregorio Marañón of Madrid. Juan currently works as the European Application Manager at BD Industrial Microbiology. This job role has responsibilities for the scientific support of traditional and rapid microbiology and support for alternative microbiology methods (Pre-Validation Studies on the BD FACSMicroCount™ and BD BACTEC FX) in the industrial pharmaceutical sector. Prior to that, Juan was working as Field Application specialist in BD providing scientific support for the clinical customers in BD Diagnostic Systems.
Dr. Michael Miller, President, Microbiology Consultants, LLC
Advantages and regulatory acceptance of RMMs within the industry
Dr. Michael J. Miller is an internationally recognised 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. Over the course of 25 years, he has held numerous R&D, manufacturing, quality, and consulting 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 solutions in support of RMMs, sterile and non-sterile pharmaceutical manufacturing, contamination control, isolator technology, validation and microbiological PAT. He also provides comprehensive training for his clients in the areas of rapid method validation and implementation.
Dr. Miller has authored more than 100 technical publications and presentations in the areas of rapid microbiological methods, PAT, ophthalmics, disinfection and sterilisation, is the editor of PDA’s Encyclopedia of Rapid Microbiological Methods, and is the owner of rapidmicromethods.com, a website dedicated to the advancement of rapid methods. He currently serves on the editorial board for European Pharmaceutical Review, is chairing the revision of PDA Technical Report #33: Evaluation, Validation and Implementation of New Microbiological Testing Methods, and routinely provides RMM training programs for the industry and professional organisations worldwide.
Supported by BD
BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. BD leads in patient and health care worker safety and the technologies that enable medical research and clinical laboratories. The company provides innovative solutions that help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures and support the management of diabetes.
Find out more: www.bd.com
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