Azbil BioVigilant Support Documentation
Performance Testing
Regulatory Guidance
- Rapid Methods Validation Package Guidance for EU Countries
- Recommended IMD-A Implementation Steps for EU Customers
US/FDA
- Minutes of Azbil BioVigilant FDA Teleconference, November 2011
- Minutes of Regulatory Roundtable, October 2011 US IMD Consortium Meeting
- Bryan Riley’s Recommendations for Communication IMD-A Validation Activities with FDA
- Sample FDA Research Exemption Letter for IMD-A Use
Regulatory Links
Guidance for Industry: PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance
US FDA
September 2004
Rapid Microbiology Methods: A Regulatory Viewpoint
Bryan Riley, US FDA CDER
PDA Meeting, Milan, Italy
June 2003