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)
* Use of comparability protocols
* Submission strategies
* Concept of research exemptions
Who Will Benefit:
* Microbiology
* Quality Control
* Quality Assurance
* Manufacturing
* Validation
* Regulatory Affairs
* R&D
* Discovery
* Finance
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)
* Use of comparability protocols
* Submission strategies
* Concept of research exemptions
Who Will Benefit:
* Microbiology
* Quality Control
* Quality Assurance
* Manufacturing
* Validation
* Regulatory Affairs
* R&D
* Discovery
* Finance
