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GCP Audits in a Risk-Based Environment
Session Chair(s)
Michael Hamrell, PhD, RAC
President
MORIAH Consultants, United States
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 : 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.
Speaker(s)
Using a Risk-Based Approach to CAPAs
Michael Hamrell, PhD, RAC
MORIAH Consultants, United States
President
Responding to FDA 483s and Audit Observations: Implementing CAPA and Applying Root Cause Analysis
Gloria Miller, RAC
ADAMAS Consulting LLC, United States
Consultant
Responding to FDA 483s and Audit Observations: Implementing CAPA and Applying Root Cause Analysis
Debra P. Farrow, RN
Bristol-Myers Squibb Company, United States
Senior Compliance Auditor
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