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CDER Small Business and Industry Assistance Webinar – Microbiology Issues: A Deep Dive – March 15th, 2017

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CDER Small Business and Industry Assistance Webinar – Microbiology Issues: A Deep Dive – March 15th, 2017

CDER Guidance Webinar pharmacmc.com

CDER Webinar – Microbiology Issues: A Deep Dive – March 15th, 2017

Pre-approved eligibility by RAPS for up to 3 credits

towards a participant’s RAC re-certification upon full completion.

 

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

These events focus on a specific topic and provide a useful 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.

CDER invites you to this LIVE free webinar “CDER Microbiology Issues: A Deeper Dive” to be held on March 15th from 10:00am – 2:30pm (Eastern US).

Join 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 analysis of 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

 

CDER Small Business and Industry Assistance Webinar - Microbiology Issues: A Deep Dive

 



More details on how to register via the link below.

Register for this webinar

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