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GCP Audits in a Risk-Based Environment

Track:
Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice

Day & Time:
June 18, 10:30AM - 12:00PM (Pacific Standard Time)

Session Number:
342

Room Number:
8

Level:
Intermediate

Type:
Forum

Title:
GCP Audits in a Risk-Based Environment

Chair(s):
Michael R. Hamrell, PhD, RAC
President
MORIAH Consultants, United States

Description:
This forum will look at how a robust Corrective and Preventative Actions (CAPA) process is an essential component of a company’s quality system. Included in these CAPA elements is the requirement of a mechanism to verify that the actions taken to correct and prevent the nonconformance were effective.

Learning Objective(s):
Recognize use of GCP audits in a risk-based environment; Define clear metrics for the success of GCP reporting; Identify how to use Corrective and Preventative Actions (CAPA) findings to enhance GCP compliance assessment.

Presentation(s) & Speaker(s):
Using a Risk-Based Approach to CAPAs
Michael R. Hamrell, PhD, RAC
President
MORIAH Consultants, United States

Responding to FDA 483s and Audit Observations: Implementing CAPA and Applying Root Cause Analysis
Gloria Katherine Miller, RAC
Senior Auditor
Premier Research, United States

Responding to FDA 483s and Audit Observations: Implementing CAPA and Applying Root Cause Analysis
Debra P. Farrow, RN
Senior Compliance Auditor
Bristol-Myers Squibb Company, United States