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Integrating Risk and Complaint Management, an R&Q Webinar
October 27 @ 1:00 pm - 2:00 pm
Having strong integrated complaint and risk management processes is about more than just compliance. Watch this webinar and learn critical strategies and tactics for success. As with every R&Q webinar, all registrants will receive access to the slides and recording.
A seamless integration of risk management with complaint management has always been daunting for device manufacturers, even before the new requirements of the EU MDR and IVDR.
R&Q has supported many companies over the past decade with FDA 483’s and warning letters related to complaint management issues that could have been avoided by having strong processes with clear linkages to risk management. It’s also important to understand (and be able to communicate) that having strong integrated complaint and risk management processes is about more than just compliance.
Efficiencies in complaint handling and faster customer responses, easier identification of the risks associated with complaints so that resources can be focused on ensuring safe and effective products, and less frustration across the impacted resources across multiple functions, are outcomes that bring great value to the business!
In this webinar, R&Q will:
- Present the variations in requirements across ISO 14971, 21 CFR, EU MDD and MDR, and IVDD and IVDR, and clearly define what’s new;
- Discuss the value of integrated complaint and risk management processes;
- Define the data inputs and outputs for risk management and complaint management, along with PMS reports, PMCF and CERs, and how that are interrelated;
- Provide best practices for your quality system to ensure linkages between Risk Management, PMS, PMCF, and Clinical, to ensure data is consistently reported and flows between these subsystems; and
- Provide guidance on how to share information throughout the organization to streamline processes and ensure consistency.