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Effectiveness Checks in the Clinical Research Setting
Program Code:
138
Date:
Monday, June 24, 2013
Time:
2:30 PM to 4:00 PM
EST
CHAIR
:
Cassandra Kennedy,
(SCHNON), Senior Vice President, Global Quality Assurance,
Quintiles Inc., United States
Cassandra Kennedy serves as the Sr. Vice-President for Global QA at Quintiles and is a member of the Enterprise Compliance Office. In this position, Ms. Kennedy is responsible for directing Quality Assurance for Clinical Research, Clinical Laboratory, Phase I Units, and Systems Compliance.
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SPEAKER
(S):
Kevin Wilson, (SPKNON), Manager, Global Medical Quality, Eli Lilly and Company, United States
Dr. Michael R. Hamrell is the President of MORIAH Consultants, a Regulatory Affairs/Clinical Research consulting firm located near Los Angeles, CA. He has worked in pharmaceuticals, government and biotech industries, in domestic and international regulatory affairs and clinical research.
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Description
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.