Change Management: ICH Q12 and Established Conditions (12of33) Quality - Oct. 16-17, 2019

Bhagwant Rege from CDER’s Office of Pharmaceutical Quality discusses post-approval change management. He also covers the ICH Q12 guideline as well as the term “established conditions.”
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.
Visit www.fda.gov/cd... and www.fda.gov/cd... for news and a repository of training activities.
Email: [e-mail]
Phone: [phone] I [phone]
LinkedIn: / cder-small-business-an...
Twitter: / fda_drug_info
CDER small business e-mail update subscription: updates.fda.go...