Regulatory - Biovigilant

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BioVigilant Support Documentation

Performance Testing

IMD-A USP<1223> Validation Tests
IMD-A Specificity 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

Azbil North America, Inc. - BioVigilant Division
2005 W. Ruthrauff Road, Suite 151
Tucson, AZ 85705 USA
(520) 292-2342
info@biovigilant.azbil.com

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