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Best Practices for End-to-End FDA Compliant Recalls

September 25-27, 2017
  • Arlington, VA

Hal Baden
Recall Coordinator & Distribution Logistics QA
Cordis, A Cardinal Health Company

Pearley Bhambri
Senior Director, Global Quality Systems
Hill-Rom

Maureen Bernier
Biomedical Engineer, Recall Coordinator,
CDRH, FDA Office of Compliance
DAPO, Recall Branch

Ron Brown
Team Leader
CDER/Office of Compliance, FDA

Willie Bryant
Expert Consultant
Stericycle

Amanda Combs
Recall Consultant
Stericycle

Sonali Gunawardhana
Attorney at Law
Wiley Rein LLP

Chris Harvey
Director, Recall Solutions
Stericycle

Lavinia Marinescu-Pedersen
Senior Product Defects and Recalls Advisor, Customer Complaint Center
Novo Nordisk

Hillary Medina
Senior Director, Recall Solutions
Novasyte

Nina Mezu-Nwaba, PharmD, MPH, MSc, CAPT
United States Public Health Service, Senior Scientific Reviewer
CDRH/OC/DMQ/FDA

Jeffrey Moster
Director, Post Market Surveillance
Hill-Rom

Ashley Reiber
Recall Coordinator
FDA

Adam E. Saltman, MD, PhD, FACS, FACC, FACP, FAHA
Medical Officer
CDRH Office of Compliance, FDA

Israel Santiago
Branch Chief, Recalls and Shortages Branch,
Office of Drug Security, Integrity and Recalls
CDER/Office of Compliance, FDA

Cecilia Wolyniak
Lead, Consumer Safety Officer
OEIO, DE, FDA

Hal Baden
Recall Coordinator & Distribution Logistics QA
Cordis, A Cardinal Health Company

Pearley Bhambri
Senior Director, Global Quality Systems
Hill-Rom

Maureen Bernier
Biomedical Engineer, Recall Coordinator,
CDRH, FDA Office of Compliance
DAPO, Recall Branch

Ron Brown
Team Leader
CDER/Office of Compliance, FDA

Willie Bryant
Expert Consultant
Stericycle

Amanda Combs
Recall Consultant
Stericycle

Sonali Gunawardhana
Attorney at Law
Wiley Rein LLP

Chris Harvey
Director, Recall Solutions
Stericycle

Lavinia Marinescu-Pedersen
Senior Product Defects and Recalls Advisor, Customer Complaint Center
Novo Nordisk

Hillary Medina
Senior Director, Recall Solutions
Novasyte

Nina Mezu-Nwaba, PharmD, MPH, MSc, CAPT
United States Public Health Service, Senior Scientific Reviewer
CDRH/OC/DMQ/FDA

Jeffrey Moster
Director, Post Market Surveillance
Hill-Rom

Ashley Reiber
Recall Coordinator
FDA

Adam E. Saltman, MD, PhD, FACS, FACC, FACP, FAHA
Medical Officer
CDRH Office of Compliance, FDA

Israel Santiago
Branch Chief, Recalls and Shortages Branch,
Office of Drug Security, Integrity and Recalls
CDER/Office of Compliance, FDA

Cecilia Wolyniak
Lead, Consumer Safety Officer
OEIO, DE, FDA