Navigating the Regulatory Environment for the Implementation of Alternative Microbiology Technologies - Webinar By GCPanel 2011

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