martes, 7 de marzo de 2017

CDER SBIA Half-Day Extended Webinar - CDER Microbiology Issues: A Deeper Dive – Wed. March 15th, 2017

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)
SBIA Webinar

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 ."
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
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