戻る Agenda
Effectiveness Checks in the Clinical Research Setting
Session Chair(s)
Cassandra Kennedy
Senior Vice President, Global Quality Assurance
Quintiles Inc., United States
A closed-loop Corrective and Preventative Action (CAPA) process inclusive of effectiveness checks is central to a company’s quality system. So we dare ask – why is this CAPA element not as clearly defined or employed in the clinical research/GCP space of our industry?
**Due to workshop format, seating will be limited and will be available on a first come, first served basis.
The Boston Convention and Exhibition Center (BCEC) has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive at workshops early in order to ensure seating. Please note, as a workshop with interactivity, this event will not be recorded.
Learning Objective : Identify systematic mechanisms to identify trends in nonconformances from individual clinical research sites; Construct a root cause analysis of the non-conformance trends and identify corrective and preventative actions; Design a valid methodology to quantify the effectiveness of those actions.
Speaker(s)
Facilitator
Kevin J Wilson
Eli Lilly and Company, United States
Manager, Global Medical Quality
Facilitator
Michael Hamrell, PHD, RAC
MORIAH Consultants, United States
President