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





CAI







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.


Tickets

The numbers below include tickets for this event already in your cart. Clicking "Get Tickets" will allow you to edit any existing attendee information as well as change ticket quantities.
Single Admission - Product Complaints & Adverse Events
Main conference & inclusive workshops
$ 2,195.00 $ 1,895.00 $1,895.00
Unlimited
Team Discount - Register 3 with 4th Free - Product Complaints & Adverse Events
Team Discount - Register 3, 4th Free. (3x$2195)=$6585 with 4th Free.
$ 1,646.25 $ 1,421.25 $1,421.25
Unlimited

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



Tickets

The numbers below include tickets for this event already in your cart. Clicking "Get Tickets" will allow you to edit any existing attendee information as well as change ticket quantities.
Single Admission - Product Complaints & Adverse Events
Main conference & inclusive workshops
$ 2,195.00 $ 1,895.00 $1,895.00
Unlimited
Team Discount - Register 3 with 4th Free - Product Complaints & Adverse Events
Team Discount - Register 3, 4th Free. (3x$2195)=$6585 with 4th Free.
$ 1,646.25 $ 1,421.25 $1,421.25
Unlimited