September 21 - 23, 2020
Sheraton University City Hotel,
Proactively Identify Industry Complexities, Regulatory Guidelines and Innovative Best Practices for Risk Management
In its 16th year, this leading event provides strategies for organizations to prevent future recalls and complaints. Interactive and engaging sessions have been designed to address FDA regulations, upcoming trends, risk-based decision making and ways to navigate automation processes.
What to Expect
Complaint Analysis and Reporting Initiatives
- Utilizing Statistical Analytics to Set Complaint Thresholds
- Trend Analytics – Leveraging AI and Automation
- Post-Market Safety Reporting for Combination Products
- Impacts of Connectivity-Devices on the Complaint Handling Process
- Complaint Handling of Traditional vs. Connected Devices
- Review Single Patient INDs and the Right-to-Try Law
End-To-End Recall Management
- Process Review and Strategic Approaches to Recall Execution
- Defining Recalls – Identifying Enhancements and Acceptable Defect Rates
- Bolster Quality Management System for Recall Prevention
- Hospital Insight into Best Recalls and Complaints Practices and Regulatory Expectations
- Post-Market Risk Monitoring for Digital Medical Devices
- Conducting Health Hazard Evaluations (HHE) Through Critical Thinking Processes
Gain Insight & Updates from FDA and Industry Leaders
(2018/2019 Speaker Highlights)
- Cecilia Wolyniak, Lead Consumer Safety Officer, ORA, FDA
- George Cusatis, Associate Director Device and Digital Health, Merck
- Erik P. Mettler, Assistant Commissioner, MPA, MPH, ORA, FDA
- Khaudeja Bano, Senior Medical Director, Medical Device Safety Head, Abbott
Download the 2020 Preview
See all the latest updates for Informa Connect–CBI’s Product Recalls & Complaints Congress.
Connect and Network with Key Decision-Makers at Product Recalls & Complaints
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