In-Person Workshop C — Master Class on Cosmetics Adverse Events Reporting, and Recalls under MoCRA: A Blueprint for Designing Your Safety Plan
Diane C. McEnroe
Dr. Rick Kingston
President of Regulatory and Scientific Affairs & Co-founder
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