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