Drugs

CDER Small Business and Industry Assistance (CDER SBIA) Webinar - CDER Microbiology Issues: A Deeper Dive - March 15th, 2017

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The Food and Drug Administration, Center for Drug Evaluation and Research and Small Business and Industry Assistance (CDER SBIA), invites you to our webinar series.

These events focus on a specific topic and provide an opportunity for small business and industry entities to learn more about the FDA and basic drug regulation. The webinars support CDER SBIA’s mission of promoting productive interaction with regulated industry by assisting small pharmaceutical business and industry with information relating to the development and regulation of human drug products.

On March 15, 2017 CDER SBIA hosted a LIVE webinar titled"CDER Microbiology Issues: A Deeper Dive". 

Our experts from the Office of Pharmaceutical Quality (OPQ) elaborated on several microbiology topics which were presented at previous SBIA events, "Pharmaceutical Quality Symposium 2016disclaimer icon" and "Focus on CGMPs & FDA Inspectionsdisclaimer icon." This extended webinar format, with Q&A sessions, is intended to provide a much deeper, scientific look at the following specific microbiology issues:

  1. The Division of Microbiology Assessment:  Organizational Overview and Recommendations for Nonsterile Products
  2. CDER Case Study: A Microbial Investigation of Contamination by Burkholderia multivorans
  3. Building a Better Sterility Assurance Application
  4. Aseptic Processing of Biological Products: Current Regulatory Issues


For questions concerning the webinar, please contact CDER SBIA at:
(866)-405-5367 | (301)-796-6707

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