In-Person Workshop C — Master Class on Cosmetics Adverse Events Reporting, and Recalls under MoCRA: A Blueprint for Designing Your Safety Plan

Mar 29, 2023 2:00pm – 05:30 PM

Diane C. McEnroe
Sidley Austin

Dr. Rick Kingston
President of Regulatory and Scientific Affairs & Co-founder
SafetyCall International

Ryan Gooley
Director, Business Development – Recall & Remediation

Safety is the core element of MoCRA legislation. Among other things, the law has given FDA mandatory recall authority and created adverse events reporting requirements. Understanding how to execute a recall has always been a critical competency for legal and business executives in these industries. However, MoCRA has taken the concept to a whole new level. This Master Class will ensure that you are prepared for the inevitability of a recall, how to develop and implement MoCRA compliant plans for recall execution, as well as AER reporting.

  • 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?
  • Implementing Adverse Event reporting protocols in compliance with MoCRA?
  • When and what AER instances are manufacturers now required to report?
  • Invoking crisis management protocols