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 – 12:15PM

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

12:15PM – 1:15PM


1:15PM – 2:15PM

Focus on How the QS Can Help Prevent Recalls and Enable Successful Recall Management
Patrick Caines, Ph.D., Senior Director, Quality and Compliance, BAXTER HEALTHCARE CORPORATION

2:15PM – 3:00PM

Case Study: Learn How to Manage Drug Recalls Better in the Future
Sameer Thapar, Adjunct Professor, Drug Safety and Pharmacovigilance, Department of Pharmaceutical Sciences, TEMPLE UNIVERSITY SCHOOL OF PHARMACY

3:00PM – 3:30PM

Networking Break

3:30PM – 4:15PM

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

4:15PM – 5:00PM

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

Day Two


8:00AM – 9:15AM

Continental Breakfast

9:30AM – 10:15AM

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

10:15AM – 11:00AM

Develop a Recall Playbook
Michael Reid, Project Manager - Post Market Quality, RESMED

11:00AM – 11:30AM

Networking Break

11:30AM – 12:30PM

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

12:30PM – 1:30PM


1:30PM – 2:15PM

Best Practices During an Inspection
Vaishali Shukla, Head of Clinical QA and Product Quality Management, uniQure

2:15PM – 3:00PM

EU Perspective to Product Quality Complaints, Defect Reporting and Market Action
Rob Smyth, Product Quality Service Lead, SHIRE