Quality Metrics, Quality Culture, and Data-Driven Decisions (16of33) Quality – Oct. 16-17, 2019 скачать в хорошем качестве

Quality Metrics, Quality Culture, and Data-Driven Decisions (16of33) Quality – Oct. 16-17, 2019

Tara Gooen from CDER’s Office of Pharmaceutical Quality discusses a set of quality metrics which may be useful for manufacturers without a current quality metrics program. She identifies characteristics of a manufacturer’s quality metrics program with strong maturity and weak maturity, shares current FDA quality metrics, and reviews site visit and feedback programs. Learn more at: https://www.fda.gov/drugs/cder-small-... _______________________________ FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research. Visit https://www.fda.gov/cdersbia and https://www.fda.gov/cdersbialearn for news and a repository of training activities. Email: CDERSBIA@fda.hhs.gov Phone: (301) 796-6707 I (866) 405-5367 LinkedIn:   / cder-small-business-and-industry-assistance   Twitter:   / fda_drug_info   CDER small business e-mail update subscription: https://updates.fda.gov/subscriptionm...