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Best Practices for End-to-End FDA Compliant Recalls

September 25-27, 2017
  • Arlington, VA

In its 13th year, CBI’s Product Recalls Summit brings together recall professionals in the life sciences industry to discuss efficient and effective recall execution strategies to comply with agencies expectations. Through interactive and engaging content, this conference showcases industry case studies, the latest recall trends, general best-practices and the opportunity to hear directly from regulators on FDA expectations.

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RAC Credits Available*

With breakouts for pharmaceutical, medical device and consumer recalls, attendees from all fields will understand how to properly handle a recall to avoid threat to reputation, brand and revenue. You’ll also hear about the Office of Regulatory Affairs Program Alignment Initiative and how the restructuring impacts the industry.

7 FDA Speakers Confirmed:

Hear Directly From Regulators on FDA Expectations and More!
  • Ron Brown, Chief, Recall Branch, FDA/CDRH/OC/DAPO
  • Maureen Bernier, Biomedical Engineer, Recall Coordinator,
    CDRH, FDA Office of Compliance, DAPO, Recall Branch
  • Adam E. Saltman, MD, PhD, FACS, FACC, FACP, FAHA,
    Medical Officer, CDRH Office of Compliance, FDA
  • Nina Mezu-Nwaba, PharmD, MPH, MSc, CAPT, United States
    Public Health Service, Senior Scientific Reviewer, CDRH/OC/DMQ/FDA
  • Ashley Reiber, Recall Coordinator, FDA
  • Cecilia Wolyniak, Lead, Consumer Safety Officer, OEIO, DE, FDA
  • Israel Santiago Branch Chief, Recalls and Shortages Branch, Office of
    Drug Security, Integrity and Recalls, CDER/Office of Compliance, FDA

CUSTOMIZE YOUR OWN LEARNING:

Choose Between Featured 90-Minute Sessions
  • Senior-Level Think Tank — Assessment Leading to a Recall
  • Recall Fundamentals and How to Improve Recall Strategies
    from Start to Finish
  • Drug Recalls — Understand the Distinctive Requirements When
    Dealing with Different Drug Recalls
  • Device Recalls —
    Benefit/Risk Factors to Consider in Medical Device Compliance
  • Ensure Timely and Effective Recall Communication to Minimize
    the Impacts on Brand and Reputation
  • Best Practices to Prepare for Audits and Inspections
  • How to Build a Globally Integrated Recall Process
  • New ORA Program Alignment —
    How the Restructuring Impacts You!

* This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Previous Attendee Acclaim:

This meeting provided me with a good basis on
key points for a successful recall.

Clinical Risk Coordinator, Care Fusion

Strong FDA representation and engagement along with
great participant discussion.

Director, Post-Approval Quality, Actavis

The industry expertise at this conference is impressive
and represents ‘best of class’ practices.

Legal Counsel, Philips Healthcare

Valuable, actionable information from the FDA.
Best ever.

Senior Manager, Ikaria Inc.

September 25-27, 2017 | Doubletree by Hilton | Arlington, VA