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.
CDER is making available the webinar "Revised Draft Guidance for Industry: Submission of Quality Metrics Data" which provides an overview of and summarizes changes in the revised draft guidance.
Michael Kopcha, Ph.D., R.Ph.
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER)
Food and Drug Administration (FDA)
Tara Gooen Bizjak
Senior Science Policy Advisor
Division of Regulations, Guidance, and Standards
Office of Policy for Pharmaceutical Quality (OPPQ) | OPQ | CDER | FDA
Acting Branch Chief
Division of Quality Intelligence and Risk Analysis and Modeling,
Office of Surveillance (OS) | OPQ | CDER | FDA
For questions concerning the webinar, please contact CDER SBIA at:
(866)-405-5367 | (301)-796-6707
- View Webinar
- Webinar Slides: Submission of Quality Metrics Data
- Federal Register link
- Submission of Quality Metrics Data Guidance for Industry
- Quality Metrics for Drug Manufacturing
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