CDER SBIA is excited to present our first extended LIVE webinar "CDER Microbiology Issues: A Deeper Dive" to be held on Wednesday March 15th from 10:00am – 2:30pm (EST).
Join us as our experts from the Office of Pharmaceutical Quality (OPQ) elaborate on several microbiology topics which were presented at previous SBIA events, "Pharmaceutical Quality Symposium 2016 " and "Focus on CGMPs & FDA Inspections ."
Join us as our experts from the Office of Pharmaceutical Quality (OPQ) elaborate on several microbiology topics which were presented at previous SBIA events, "Pharmaceutical Quality Symposium 2016 " and "Focus on CGMPs & FDA Inspections ."
This extended webinar format, with Q&A sessions, is intended to provide a much deeper, scientific look at the following specific microbiology issues:
- The Division of Microbiology Assessment: Organizational Overview and Recommendations for Nonsterile Products
- CDER Case Study: A Microbial Investigation of Contamination by Burkholderia multivorans
- Building a Better Sterility Assurance Application
- Aseptic Processing of Biological Products: Current Regulatory Issues
The event is free and has been pre-approved by RAPS as eligible for up to 3 credits towards a participant’s RAC recertification upon full completion.
For questions concerning the webinar, please contact CDER SBIA at:
(866)-405-5367 | (301)-796-6707
(866)-405-5367 | (301)-796-6707
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