Candace Gomez-Broughton from CDER’s Office of Pharmaceutical Quality discusses quality microbiology content of CDER biologics license applications submissions and guidance documents and regulations. She also covers process validation common deficiencies such as sterilizing filtration, post-reconstitution and post-dilution storage, container closure integrity, and drug product quality micro content for BLAs.
Learn more at www.fda.gov/dr...
_______________
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
Upcoming training and free continuing education credits: www.fda.gov/cd...
CDER SBIA 2020 Playlist: • 2020 CDER Small Busine...
LinkedIn: / cder-small-business-an...
Training resources: www.fda.gov/cd...
Twitter: / fda_drug_info
CDER small business e-mail update subscription: updates.fda.go...
Email: CDERSBIA@fda.hhs.gov
Phone: (301) 796-6707 I (866) 405-5367
12 апр 2020
