SBIA Education Events

US FDA – Center for Drug Evaluation & Research – Small Business & Industry Assistance

CDER Microbiology Issues: A Deeper Dive – Files Page

March 15, 2017:

The Division of Microbiology Assessment: Organizational Overview and Recommendations for Nonsterile Products
Erika Pfeiler, PhD
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CDER Case Study: A Microbial Investigation of Contamination by Burkholderia multivorans
John Metcalfe, PhD
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Q&A Session for the above two presentations
Erika A. Pfeiler and John Metcalfe
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Building a Better Sterility Assurance Application
Marla Stevens-Riley, PhD
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Aseptic Processing of Biological Products: Current Regulatory Issues
Candace Gomez-Broughton, PhD
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Q&A Session for the above two presentations
Marla Stevens-Riley and Candace Gomez-Broughton
Click for Recording