Mini Workshop

Oversight of RBQM with a CRO

Thursday, September 30, 2021, 9:45 AM - 11:15 AM

Continuing the learnings from Leslie Sam’s session on Outsourcing Oversight of QbD, this mini-workshop delves into meeting the regulatory authority expectations for on-going vendor oversight of the sponsor’s delegation of RBQM to their vendor. Attendees will evaluate the foundational requirements for vendor oversight (procedures, processes, training, vendor oversight plan), and determine the critical — to — quality duties, functions, and activities for their outsourced RBQM. Attendees will also evaluate their resourcing models and headcount that ensures there are enough staff, who are qualified for RBQM vendor oversight, assigned to their clinical programs. This will be an interactive, engaging, live virtual workshop with Liz Wool.

Faculty: