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Recent Enforcement Updates • Risk-based Decision Making • Navigation of Global Requirements

September 16-18, 2019
  • Silver Spring, MD

CBI’s Life Sciences Recalls, Returns & Removals Summit brings together professionals in the life sciences industry with responsibilities in the recall process and product return operations. Regardless of experience level, length of time working in recalls or returns, or whether it’s drugs, devices, or healthcare related services, you will benefit from the program agenda and distinguished speakers.

By attending, you’ll gain multi-stakeholder perspectives and an all-encompassing view of end to end recall execution. Don’t miss the opportunity to delve into current processes to enable stronger communication plans and risk management.

Join Your Peers to Learn and
Share Concepts on Topics Including:

  • Examine additional requirements of the EU Medical Device Regulations and how they impact manufactures
  • The Final Rule and its Impact on the Implementation of
    Unique Device Identification Numbers (UDI)
  • Delve into hospital recall practices to provide industry insights into the field to better manage activities
  • Mitigate risk and failures to avoid field corrections and recalls
  • Navigate the expectations and requirements of
    international markets

New This Year!

  • Recalls and Corrective Actions for Digital Medical Devices
  • The Evolution of Serialization and the Impacts on Supply Chain
  • Identify software enhancements versus recalls
  • Case study — Combination Products — HHE Class I
  • Strategies and best practices for effectively coordinating recalls globally
  • AND! Hospital & Pharmacy Recall Best Practices

FDA Notable Speakers:

FDA KEYNOTE ADDRESS
Erik P. Mettler
Assistant Commissioner, MPA, MPH, ORA

Cecilia Wolyniak
Lead Consumer Safety Officer, ORA

Sandy Weininger
Senior Electrical/Biomedical Engineer

Dyana Stone
Consumer Safety Officer, ORA

Previous Attendee Acclaim:

Great information and perspectives from FDA, manufacturers, distributors and health care.

Technology Transfer Specialist, BioFire Diagnostics, Inc.

This is the first seminar that I have been at the took as many stake holders into account as possible. We had industry, FDA, hospital representation and 3rd party service providers.
The insight from each was very valuable and will help
me craft the future of Recalls for my organization.

Senior Manager, Quality Assurance, Stryker

Good information exchange and sharing between FDA, providers, and industry.

Senior Director, Quality and Compliance, Baxter Healthcare

Very informative.

Quality Systems, Fresenius Medical Care

Life Sciences Recalls, Returns & Removals Summit

Recent Enforcement Updates • Risk-based Decision Making • Navigation of Global Requirements

CBI’s Life Sciences Recalls, Returns & Removals Summit brings together professionals in the life sciences industry with responsibilities in the recall process and product return operations. Regardless of experience level, length of time working in recalls or returns, or whether it’s drugs, devices, or healthcare related services, you will benefit from the program agenda and distinguished speakers.

By attending, you’ll gain multi-stakeholder perspectives and an all-encompassing view of end to end recall execution. Don’t miss the opportunity to delve into current processes to enable stronger communication plans and risk management.

Join Your Peers to Learn and
Share Concepts on Topics Including:

  • Examine additional requirements of the EU Medical Device Regulations and how they impact manufactures
  • The Final Rule and its Impact on the Implementation of
    Unique Device Identification Numbers (UDI)
  • Delve into hospital recall practices to provide industry insights into the field to better manage activities
  • Mitigate risk and failures to avoid field corrections and recalls
  • Navigate the expectations and requirements of
    international markets

New This Year!

  • Recalls and Corrective Actions for Digital Medical Devices
  • The Evolution of Serialization and the Impacts on Supply Chain
  • Identify software enhancements versus recalls
  • Case study — Combination Products — HHE Class I
  • Strategies and best practices for effectively coordinating recalls globally
  • AND! Hospital & Pharmacy Recall Best Practices

FDA Notable Speakers:

FDA KEYNOTE ADDRESS
Erik P. Mettler
Assistant Commissioner, MPA, MPH, ORA

Cecilia Wolyniak
Lead Consumer Safety Officer, ORA

Sandy Weininger
Senior Electrical/Biomedical Engineer

Dyana Stone
Consumer Safety Officer, ORA

Previous Attendee Acclaim:

Great information and perspectives from FDA, manufacturers, distributors and health care.

Technology Transfer Specialist, BioFire Diagnostics, Inc.

This is the first seminar that I have been at the took as many stake holders into account as possible. We had industry, FDA, hospital representation and 3rd party service providers.
The insight from each was very valuable and will help
me craft the future of Recalls for my organization.

Senior Manager, Quality Assurance, Stryker

Good information exchange and sharing between FDA, providers, and industry.

Senior Director, Quality and Compliance, Baxter Healthcare

Very informative.

Quality Systems, Fresenius Medical Care