Product Complaints

Handling product complaints has always been a regulatory hot issue for both the FDA and other global regulators. In fact, there have been a flurry or Warning Letters on handling complaints in the last few years and the FDA had recently issued two guidance documents on product recalls. The time has never been great to ensure you have established best in class procedures for receiving, reviewing, and evaluating pharmaceutical and medical device 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 with inclusive workshops on adverse events and product recall and network with your peers to ensure you up-to-the-minute modern processes in place to master these critical areas.

PRODUCT COMPLAINTS HIGHLIGHTS:

• Compliance Intelligence – FDA and Global Regulations, Compliance Trends and Warning Letters
• Building an Effective and Customer-Centric Complaints Team
• Intake and Triage – Connection to the Customers
• Enhance Processes to Effectively Manage Complaints Through Documents and Records Control
• Initiating, Performing and Documenting a Complaint Investigation
• How to Use Risk-based Decision Making in Handling Complaints
• Assessing and Determining the Scope of Potential Product Impact
• Utilize Data Analytics to Obtain Actionable Product ComplaintsInsights and Streamline Handling Processes
• Learn How to Effectively Utilize CAPA in the Complaint Handling Process
• Automate Field Alerts and Actions Processes to Streamline Identification, Reporting, and Analysis
• Analyzing Clinical Data and Post-Market Surveillance and Surveys to Establish Product Complaint Process Improvement
• Effective Collaborative Complaint Investigations with your Contract Manufacturer/Supplier

PLUS! INCLUSIVE WORKHOPS ON:

PRODUCT RECALLS

• Design an Effective Product Recall and Withdrawal Strategy
• Strategies to Ensure Product Recall Tracking and Reporting Accuracy
• Risk Assessment and Mitigation for Recall Decision Making
• Implement an Effective CAPA Management System to Ensure Accurate and Compliant Product Investigations

ADVERSE EVENTS

• Develop an Effective Program to Receive, Investigate, Document, Report Adverse Events
• Developing Robust Adverse Events Risk Management Processes and Execution Strategies
• Establish FDA Compliant Adverse Events Cross-Functional Communications – Driving the Lessons INTO the Organization – Organic Learning Opportunities
• Using social media as a Tool to Gather Information about Product Complaints and Adverse Events