subject: Navigating the Regulatory Environment for the Implementation of Alternative Microbiology Technologies - Webinar By GCPanel [print this page] Navigating the Regulatory Environment for the Implementation of Alternative Microbiology Technologies - Webinar By GCPanel
Overview: Rapid microbiological methods (RMMs) have been implemented by a number of companies around the world. In some cases, it is necessary to work with regulatory authorities in order to effectively introduce a RMM in place of an existing microbiology method.
This is especially true if the existing method is incorporated in a previously approved regulatory dossier, such as a New Drug Application (NDA) or Marketing Authorization. There are different perspectives on RMM validation, submission and implementation strategies, depending on the regulatory body your products are registered with, and/or which local inspectorate is responsible for conducting GMP audits at your manufacturing facilities.
Rapid microbiological methods (RMMs) have been implemented by a number of companies around the world. In some cases, it is necessary to work with regulatory authorities in order to effectively introduce a RMM in place of an existing microbiology method. This is especially true if the existing method is incorporated in a previously approved regulatory dossier, such as a New Drug Application (NDA) or Marketing Authorization. There are different perspectives on RMM validation, submission and implementation strategies, depending on the regulatory body your products are registered with, and/or which local inspectorate is responsible for conducting GMP audits at your manufacturing facilities.
Areas Covered in the Session: Review current regulatory status of rapid method acceptance
Regulatory publications and presentations focusing on RMM implementation
Current perspectives from the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Australian Therapeutic Gods Administration (TGA) and the Japanese Pharmaceutical and Medical Devices Agency (PMDA)
