Agenda – 2018 Product Recalls Forum

  • Day One
  • Day Two

Day One


9:15AM – 10:00AM

Best Practices to Help Understand the Fundamentals of Recalls in Your Organization
Joe Falvo, Senior Manager: Postmarket Risk Management, ORTHO CLINICAL DIAGNOSTICS

10:00AM – 10:45AM

Methods and Strategies for a Recall Execution: Why Create a Recall Strategy
Joe Falvo, Senior Manager: Postmarket Risk Management, ORTHO CLINICAL DIAGNOSTICS

10:45AM – 11:15AM

Networking Break

11:15AM – 12:00PM

FDA Keynote
Maureen M. Bernier, MME, PE, Biomedical Engineer, Recall Coordinator, FDA

12:00PM – 1:00PM


1:00PM – 1:45PM

Recall Management Planning for the Unexpected — Prepare for a Mock Recall to Help Strengthen Your Action Plan
Pearley Bhambri, Senior Director Global Quality Systems and Post Market Surveillance, HILL-ROM

1:45PM – 2:30PM

Develop a Recall Playbook
Alex Patterson, Director Post Market Quality, RESMED

2:30PM – 3:00PM

Networking Break

3:00PM – 3:45PM

Case Study: Learn How to Manage Drug Recalls Better in the Future
Sameer Thapar, Assistant Professor and Advisor, Drug Safety and Pharmacovigilance, RUTGERS UNIVERSITY

3:45PM – 4:30PM

Understand the Operations of Recalls and Field Actions
Katherine May, APM Predict Product Manager (XLP — Accelerated Leadership Program), GE HEALTHCARE

4:30PM – 5:15PM

Analytical Testing for Product Complaints and Suspect Products for Product Recalls
Ravi Kalyanaraman, Ph.D., Associate Director, BRISTOL-MYERS SQUIBB

Day Two


8:00AM – 8:45AM

Continental Breakfast

9:00AM – 9:45AM

Compounding Recall Process and Industry Trends
Melissa Stefko, Senior Director of Quality Assurance, WELLS PHARMACY NETWORK

9:45AM – 10:30AM

Best Practices During an Inspection
Jennifer Judge, Post Market Compliance, Regulatory Affairs, WELCH ALLYN

10:30AM – 11:15AM

Networking Break

11:15AM – 12:00PM

MDR Reporting and Procedures for Completing Reports
Michael Van Ryn, Director, Post Market Regulatory Compliance, STRYKER

1:15PM – 2:15PM


2:15PM – 3:00PM

EU Perspective to Product Quality Complaints, Defect Reporting and Market Action
Noel Gaule, Head of Product Quality Surveillance, QP, SHIRE