DIA 48th Annual Meeting
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Misconduct and Management of Serious or Continued Noncompliance: What Are the Differences and Similarities?
Track
:
Track 11: Compliance to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Quality Assurance (QA)
Program Code:
229
Date:
Tuesday, June 26, 2012
Time:
10:00 AM to 11:30 AM
EST
CHAIR
:
Deborah Waltz, Pfizer Inc, United States
PRESENTER
(S):
James Huang, Forest Research Institute, United States Constance Cullity, FDA, United States
Description
This session will provide regulatory perspective on new enforcement directives which place greater emphasis on accountability for compliance for all parties involved in the research enterprise.
Learning Objectives:
Describe the current FDA compliance expectations for sponsors and investigators
Differentiate between manageable/correctable non-compliance and serious or continued non-compliance and scientific misconduct
Discuss strategies for appropriate management and escalation techniques.
Learning Objectives:
Describe the current FDA compliance expectations for sponsors and investigators
Differentiate between manageable/correctable non-compliance and serious or continued non-compliance and scientific misconduct
Discuss strategies for appropriate management and escalation techniques.
This session is a part of:
Handout Online
