Quality Risk Management: Using Risk Assessments in Manufacturing (3B)

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Tuesday, 5 June 2012, 11.00 – 12.30

Moderator: Michael Smedley, Deputy Director, Office of Manufacturing and Product Quality, QC, CDER, FDA, USA

It is well accepted in the industry and FDA that the use of sound scientific and quality risk management approaches throughout the lifecycle are critical to establishing and maintaining a state of control. But how does a company tangibly achieve this objective?

This session will use examples from industry and regulatory perspectives to show how the use of risk assessment helps identify failure modes in an operation and promotes development of risk mitigation approaches to control sources of variability. You will learn how good planning of facilities and processes, strong monitoring systems and a quality assurance mindset throughout your operation will prevent risks to product quality.

Discussion on the importance of taking advantage of contemporary technology and systems to achieve better processes to provide both business and consumer benefits will also be presented.

At the conclusion of this session participants will be able to:

Understand the advantages of using scientific and quality risk management approaches to promote strong science-based decisions
Utilize modern technology and quality systems approaches to meet business and drug quality objectives
Understand how lifecycle continual improvements are assured through good monitoring systems and a strong quality assurance mindset.

Session Agenda

11.00 – 12.30
Quality Risk Management: Using Risk Assessments in Manufacturing
Session Moderator: Michael Smedley, Deputy Director, Office of Manufacturing and Product Quality, OC, CDER, FDA

11.00 – 11.40
Modernization and Its Role in Quality Risk Management
Rick Friedman, Associate Director for Risk Science Intelligence and Prioritization, OMPQ, OC, CDER, FDA

11.40 – 12.15
Case Studies:Identifying and Addressing Quality Risks Throughout the Lifecycle
Chris Milano, PhD, Senior Director, Quality Operations, Merck

12.15 - 12.30
Question & Answer Session

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