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

  • 29 Mar 2011
  • Webinar

Description

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

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Important

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Event Categories

Education: Training
Health & Medicine: Hospitals & Clinics, Medical device, Medical laboratories, Medical technology, Pharma

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