On Sept. 9, FDAnews will offer the webinar, Managing Risk for Clinical Trials: Incorporating Quality by Design and Risk Management Strategies.
With more than 50 years of combined experience, expert presenters Sherri Hubby and Brian Nugent will share insights that can be used to establish Risk Based Monitoring plans, including triggers for return to 100% source data verification.
The webinar will outline how to proactively identify and manage risks to trial with methods that can immediately be implemented and used. QbD examples such as failure-modes-and-effects and criticality analysis (FMECA), Isikawa/Fishbone Diagrams, and Hazard Analysis and Critical Control Points will be explained.