Workshop C – Recall Master Class: An Essential Guide to Cosmetics Adverse Events Reporting, and Recalls under MoCRA for Small and Large Companies

Sep 29, 2023 2:00pm – 05:30 PM

Jessica Ringel
Partner
King & Spalding

Ryan Gooley
Director, Business Development – Recall & Remediation
Sedgwick

The safety of consumers is at the heart of the MoCRA legislation, which grants the FDA mandatory recall authority and mandates adverse event reporting requirements for the cosmetics and personal care industries. With the stakes higher than ever, it’s critical for legal and business executives to have the necessary competencies to execute a recall effectively.

In this resource and training session, our workshop leaders will provide practical guidance on how to develop and implement MoCRA compliant plans for recall execution and adverse event reporting.

In addition to:

  • Examining FDA’s recall and oversight authority with cosmetics and personal care products under MoCRA
  • Identifying events which would trigger a mandatory recall under MoCRA
  • Developing best practices to design and implement an FDA-mandated MoCRA recall
  • Examining circumstances in which a voluntary recall is warranted
    • What is the nature of the recall?
    • What corrective actions should be taken?

Participants will gain insights on the following:

  • Preparing for a recall:
    • Examining the steps companies need to take to prepare for recalls and adverse events
    • Exploring best practices for developing and implementing effective plans
  • MoCRA-compliant recall execution:
    • Detailing the specific requirements for executing a recall in compliance with MoCRA, including notification and record-keeping requirements
  • Adverse event reporting:
    • Highlighting the importance of adverse event reporting in promoting safety and compliance, and outlining best practices for executing reporting requirements
  • Crisis Management Protocols
    • Determining the right messaging during a recall
    • Winning back public trust and consumer confidence-post recall