NAVIGATING THE REGULATORY ENVIRONMENT FOR THE IMPLEMENTATION OF ALTERNATIVE MICROBIOLOGY TECHNOLOGIES – WEBINAR BY GCPANEL
by admin on Jun.26, 2011, under Microbiology
Overview: Rapid microbiological methods (RMMs) have been implemented by a series of companies around a world. In a little cases, it is required to work with regulatory authorities in sequence to effectively deliver a RMM in place of an existent microbiology method.
This is generally loyal if a existent process is incorporated in a formerly authorized regulatory dossier, such as a New Drug Application (NDA) or Marketing Authorization. There have been opposite perspectives upon RMM validation, acquiescence as well as doing strategies, depending upon a regulatory physique your products have been purebred with, and/or that internal inspectorate is obliged for conducting GMP audits during your production facilities.
Rapid microbiological methods (RMMs) have been implemented by a series of companies around a world. In a little cases, it is required to work with regulatory authorities in sequence to effectively deliver a RMM in place of an existent microbiology method. This is generally loyal if a existent process is incorporated in a formerly authorized regulatory dossier, such as a New Drug Application (NDA) or Marketing Authorization. There have been opposite perspectives upon RMM validation, acquiescence as well as doing strategies, depending upon a regulatory physique your products have been purebred with, and/or that internal inspectorate is obliged for conducting GMP audits during your production facilities.
Areas Covered in a Session: Review stream regulatory standing of fast process acceptance
Regulatory publications as well as presentations focusing upon RMM implementation
Current perspectives from a U.S. Food as well as Drug Administration (FDA), European Medicines Agency (EMA), Australian Therapeutic Gods Administration (TGA) as well as a Japanese Pharmaceutical as well as Medical Devices Agency (PMDA)
Use of comparability protocols
Submission strategies
Concept of investigate exemptions
Who Will Benefit: Microbiology
Quality Control
Quality Assurance
Manufacturing
Validation
Regulatory Affairs
R&D
Discovery
Finance
Price List:
Live : 5.00
Corporate live : 5.00
Recorded : 5.00