Walkthrough of a Pre-Approval Manufacturing Site Inspection (14of14) REdI 2018

FDA’s Office of Regulatory Affairs’ Lucila B. Nwatu describes the general inspectional approach for FDA pre-approval inspection of sterile and biological therapeutic drug products. She includes the requirements to demonstrate the ability to operate in compliance with cGMPs, adherence to application commitments, and authenticity and accuracy of data submitted in applications.
_______________________________
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: https://www.fda.gov/cdersbia

CDER SBIA 2018 Playlist:    • 2018 CDER Small Business and Industry...  
LinkedIn:   / cder-small-business-and-industry-assistance  
Training resources: https://www.fda.gov/cderbsbialearn

Twitter:   / fda_drug_info  

CDER small business e-mail update subscription: https://updates.fda.gov/subscriptionm...

Email: [email protected]
Phone: (301) 796-6707 I (866) 405-5367