Editorial
In this product risk management webinar attendees will understand the key requirements of ISO 14971 (2007 and 2012) and ICH Q9. Also attendees will learn how to develop and implement product risk management planning through ISO 14971 & ICH Q9 to increase the product safety and reduced liability.
Objectives
Many firms use some product risk management tools, but are not compliant to ISO 14971, for devices, or ICH Q9, for pharma.
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What changes would be necessary to become compliant?
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What are Europe and U.S. regulatory expectations?
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What benefits beside regulatory compliance can be achieved for a company?
Both the U.S. FDA and the EU's MDD/MDR require companies to be proactive in reducing product risk while increasing user benefits. What "risk" is to be analyzed? One of the best tools to achieve and document this is ISO 14971 for devices or ICH Q9. Both allow leeway in the type of tools used to comply. See the elements recommended or expected to be in the Risk Management File / Report.
Learn how to blend ISO 14971 and ICH Q9. Make the document a "living" document. Achieve major business benefits by regular use of the Risk Management File / Report in training, marketing, validation, root cause analysis, CAPA activities and failure investigations, as well as the obvious, increased product safety and reduced liability.
Program
Areas Covered in the Webinar:
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Key requirements of ISO 14971 (2007 and 2012); ICH Q9
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Suggested formats
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Expected sources of information to evaluate
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What to include
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How to complete, document, and control
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An often neglected safety feature
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A "living" useful, cost-saving document