AGENDA
7:30 ET
Exhibitor Showroom Opens and Lite Breakfast
8:15 ET
Chairperson's Welcome and Opening Remarks
8:30 - 9:10 ET
CHOOSE BETWEEN TWO IN-CONFERENCE WORKSHOPS
ADVERSE EVENTS
Develop an Effective Program to Receive, Investigate, Document, Report Adverse Events
Kim Huynh-Ba, Managing Director, Pharmalytik Consulting; Adjunct Faculty, Regulatory Compliance, Illinois Institute of Technology (IIT)
PRODUCT RECALLS
Design an Effective Product Recall and Withdrawal Strategy
Rucha Patel, Manager, Quality Assurance and Regulatory Affairs, MIMOSA Diagnostics
9:20 - 10:00 ET
Select Between Knowledge Exchange Sessions
ADVERSE EVENTS
Developing Robust Adverse Events Risk Management Processes and Execution Strategies
Taylor Dieringer, Risk Management Quality Engineer, MEDIcept, Inc
PRODUCT RECALLS
Strategies to Ensure Product Recall Tracking and Reporting Accuracy
e Product Recall Tracking and Reporting Accuracy To Be Announced
10:00 ET
Exhibitor Showroom and Refreshment Break
10:30 - 11:10 ET
Select Between Knowledge Exchange Sessions
ADVERSE EVENTS
Establish FDA Compliant Adverse Events Cross-Functional Communications – Driving the Lessons INTO the Organization – Organic Learning Opportunities
Andrea Roether, Global Quality Director, Creation Technologies
PRODUCT RECALLS
Risk Assessment and Mitigation for Recall Decision Making
Taylor Dieringer, Risk Management Quality Engineer, MEDIcept, Inc.
11:20 - 12:00 ET
Select Between Knowledge Exchange Sessions
ADVERSE EVENTS
Using Social Media as a Tool to Gather Information about Product Complaints and Adverse Events
To Be Announced
PRODUCT RECALLS
Implement an Effective CAPA Management System to Ensure Accurate and Compliant Product Investigations
Sameer Kadam, Expert Solutions Engineer, Sparta Systems, A Honeywell Company
12:00 ET
Exhibitor Showroom and Networking Luncheon
1:00 ET
HANDLING PRODUCT COMPLAINTS CONFERENCE BEGINS
1:00 - 1:40 ET
Compliance Intelligence - FDA and Global Regulations, Compliance Trends and Warning Letters
Jacob Foster, MBA, Director, Quality Complaints & CAPA, Illumina
1:50 - 2:30 ET
Panel Discussion: Building an Effective and Customer-Centric Complaints Team
Moderator: Sameer Kadam, Expert Solutions Engineer, Sparta Systems, A Honeywell Company
Panelists: Ashley Bhagwatprasad, Specialist, Engineer, Customer Complaints, Merck
Kimberly Wallbank, Principal Consultant, Quality Systems Services, LLC
2:30 - 3:30 ET
Networking Break and Speed Training Sessions
3:30 - 4:10 ET
Intake and Triage – Connection to the Customers
Kimberly Wallbank, Principal Consultant, Quality Systems Services, LLC
4:20 - 5:00 ET
Critical Steps to Successfully Adhere to the FDA Incident Timeline Requirements
To Be Announced
5:00 ET
Networking Cocktail Reception
7:30 ET
Exhibitor Showroom Opens and Lite Breakfast
8:30 - 9:10 ET
Initiating, Performing and Documenting a Complaint Investigation
Yarismar Fernández-Alicea, Quality Assurance - Compliance Specialist, Emergent Biosolutions
9:20 - 10:00 ET
How to Use Risk-based Decision Making in Handling Complaints
Kimberly Wallbank, Principal Consultant, Quality Systems Services, LLC
10:00 ET
Exhibitor Showroom and Refreshment Break
10:30 - 11:10 ET
Assessing and Determining the Scope of Potential Product Impact
Patti Parekh, Principal Consultant, CAI
11:20 - 12:00 ET
Utilize Data Analytics to Obtain Actionable Product Complaints Insights and Streamline Handling Processes
Jacob Foster, MBA, Director, Quality Complaints & CAPA, Illumina
12:00 ET
Networking Luncheon
1:00 - 1:40 ET
Learn How to Effectively Utilize CAPA in the Complaint Handling Process
Yarismar Fernández-Alicea, Quality Assurance - Compliance Specialist, Emergent Biosolutions
1:40 - 2:30 ET
Automate Field Alerts and Actions Processes to Streamline Identification, Reporting, and Analysis
Sameer Kadam, Expert Solutions Engineer, Sparta Systems, A Honeywell Company
2:30 ET
Exhibitor Showroom and Refreshment Break
2:45 - 3:25 ET
Analyzing Clinical Data and Post-Market Surveillance and Surveys to Establish Product Complaint Process Improvement
Rucha Patel, Manager, Quality Assurance and Regulatory Affairs, MIMOSA Diagnostics
3:35 - 4:15 ET
Effective Collaborative Complaint Investigations with your Contract Manufacturer/Supplier
Andrea Roether, Global Quality Director, Creation Technologies
4:15 ET
Close of Conference
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.
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
