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Risk-Based Inspections and Compliance
Session Chair(s)
Rick Friedman, MSc
Deputy Director, OMQ, Office of Compliance, CDER
FDA, United States
This forum will provide attendees with exposure to regulators use of a quality risk management approach in its inspections and compliance activities. In particular, the forum will provide participants with the opportunity to understand regulatory expectations for maintaining an ongoing state of control throughout the life cycle by exercising good science and vigilant quality oversight.
Learning Objective : Describe the current risk-based approaches to inspections and compliance; Identify risk-based approaches through actual examples of inspection findings; Compare and contrast the benefits of a risk-based approach to inspections as opposed to more general audit methodologies.
Speaker(s)
GMP/GDP Management System for Medicinal Products in Taiwan
Chyn-Liang Huang, MPharm
TFDA, Taiwan
Chief Inspector/ Section Chief
Overseas GMP Inspections from Emerging Markets
Qing Shen, MS
Shanghai Roche Pharmaceutical Ltd., China
Senior Principle Technical Advisor
Compliance Update
Rick Friedman, MSc
FDA, United States
Deputy Director, OMQ, Office of Compliance, CDER
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Ways to register
Registration override should work.