In-Person Workshop B — Next Stage MoCRA Working Group: Hands-On Guidance for Adverse Event Reporting, Recalls, and GMP Compliance
Maria Celis
General Counsel
JO Cosmetics
Marcha Isabelle Chaudry, Esq.
Founder
The Equity and Wellness Collaborative
Winston S., Kirton
Partner
Baker Hostetler
Workshop is available In-Person only.
This workshop is designed to equip counsel and regulatory executives with the knowledge and practical tools needed to ensure compliance with the next stage of MoCRA compliance and deliverables. Attend and learn about MoCRA’s adverse events and recall requirements, as well as forthcoming cGMP regulations.
Key Workshop Highlights:
- Adverse Event Reporting and Recalls: Gain practical insights on establishing robust systems for monitoring and reporting adverse events, handling recalls, and ensuring compliance with MoCRA’s stringent requirements
- GMP Compliance: Develop a comprehensive cGMP compliance plan in anticipation of the FDA’s release of new cosmetics cGMPs
- Inspection Readiness: Explore best practices for preparing for FDA inspections, including how to implement preventive measures and conduct internal audits to maintain compliance
- Mitigating the risk of receiving warning letters related to GMP violations