AGENDA
Handling product complaints and recalls are (and have always been) a regulatory hot issue for both the FDA and other global regulators. In fact, there have been a flurry of Warning Letters on handling complaints in the last few years and the FDA has recently issued two guidance documents on product recalls. The time has never been greater to ensure you have established best in class procedures for receiving, reviewing, and evaluating complaints. Moreover, from Covid and beyond it is essential you have a risk mitigation plan for product recalls to ensure you can handle today’s supply chain challenges in an instant. Come and attend KENX’s Handling Product Complaints and Product Recalls forum, network with your peers and ensure you have up-to-the-minute modern processes in place to master these critical areas.
EARLY BIRD PRICING ENDS FRIDAY, OCTOBER 21
PRODUCT COMPLAINTS HIGHLIGHTS:
Initiating, Performing and Documenting a Complaint Investigation
How to Use Risk-based Decision Making in Handling Complaints
Automate Field Alerts and Actions Processes to Streamline Identification, Reporting, and Analysis
End-to-End Methods to De-Escalate Product Complaints
Utilize Data Analytics / AI to Obtain Actionable Insights and Streamline Processes
Building an Effective and Customer-Centric Complaints Team
Learn How to Effectively Utilize CAPA in the Complaint Handling Process
Critical Steps to Successfully Adhere to the FDA Incident Timeline Requirements
Using Social Media as a Tool to Gather Information about Produce Complaints and Adverse Events
Developing Robust Adverse Events Risk Management Processes and Execution Strategies
Manage Adverse Events Incidents by Reducing Risks and Optimizing Reporting Processes
PRODUCT RECALLS HIGHLIGHTS:
Review FDA’s Recent Voluntary Recalls (March ’22) and Recalls (March ’20) Final Guidance
Understand the Critical Steps to Initiate a Recall and Design an Effective Withdrawal Strategy
Learn the Key Factors to Determine Product Recall or Removal Justification
Prepare Impactful Product Recall and Removals Communication Strategies
Effective Strategies to Ensure Product Recall Tracking and Reporting Accuracy
Implement an Effective CAPA Management System
Use Risk Assessment and Mitigation for Recall Decision Making
Global Recalls – Prepare a Contingency Plan for a Large-Scale Event
Write Regulatory Compliant and Effective Public Notices and Cross-Functional Internal Communications
Strategies for Product Disposal, Effectiveness Checks and Concluding a Product Recall
Identify, Report, and Risk Assessment of Invisible Defects
Who Should Attend
- Quality Assurance/Quality Control
- Regulatory Affairs
- Quality Risk Management
- Corporate Risk Management
- Legal and Compliance Officers
- Operations, Production, and Manufacturing Directors and Managers
- General/Corporate Counsel
- Medical Affairs
- Medical Communications
- Media and Public Relations
- Complaint Handling Management
- Recall Management
- Quality Engineers
- Process Engineers
- Supply Chain