Deploying Risk-Based Thinking within Management Systems

What is risk-based thinking?

For FDA-regulated industries, there is no clearly stated definition of what risk-based thinking is, let alone clear instructions on how to take the concept of risk and deploy it throughout your entire quality management system.

However, according to the FDA, risk management should be an integral and ongoing part of any quality management process, including:

• Offer a systematic approach to quality risk management
• Promote a risk-based approach to the monitoring of clinical investigations
• Provide a basis for assessing, analyzing, and evaluating risk 

FDA-regulated industries face increased pressure to develop risk-based monitoring strategies and plans for every facet of their GxP process.

On Tuesday, April 28 at 1:30 PM EST/10:30 AM PST, experienced Technical Operations Manager, Ernest Blanchard, hosted a comprehensive webinar about the concept of risk management and risk-based thinking within management systems for GxP professionals. Specifically, how to take the concept of risk and deploy it throughout your entire quality management system.

Deploying Risk-Based Thinking within Management Systems

Topics Covered

Through the use of concrete examples, objectives for this webinar include:

• Defining risk and risk-based thinking in concrete terms
• Explaining how to score risk across departments
• Providing context for a common understanding of these terms in order to build a framework for deployment
• Understanding strategies for the promotion of risk-based thinking throughout an organization
• Providing tools to ensure that risk and risk-based thinking take into consideration risk and opportunities in the context of the quality management system

Who Will Benefit? 

This session will be valuable to quality, regulatory, compliance, and management personnel in FDA-regulated industries.

To download the slides, click here!

About the Presenter

Ernest Blanchard has over 20 years of work experience in metals, plastics, automotive, and related industries, including environmental compliance, environmental monitoring, and resource management.

Since 2016 he has attended Grand Canyon University in the College of Doctoral studies with a goal of achieving his Doctor of Business Administration. His dissertation topic aligns with the presentation as it is on Risk-based Thinking.

Blanchard has conducted management system audits across a variety of industry sectors and joined SGS in 2008 after working in several auditing positions in the management systems certification field. Since 2012, Blanchard has been a member of SGS’s management team. He has been Product Manager for IS0 14001 and OHSAS, in addition to his duties as a Veto Authority for IATF.