MARCH 26-27, 2019
Conducting Advanced Root Cause Analysis and CAPA Investigations
Raleigh, NC

MARCH 27-28, 2019
ICH GCP E6 R2 Meeting CRO-Vendor Oversight Requirements
Raleigh, NC

APRIL 8-12, 2019
FDA Compliance Boot Camp 2019
Frederick, MD

APRIL 15-18, 2019
18th Annual Design of Medical Devices Conference
Minneapolis, MN

FEBRUARY 27, 2019
FDA Medical Device Compliance and Enforcement: Lessons from Last Year and Your Game Plan for This Year

• What areas the FDA targeted in inspections in 2018 and has focused on for enforcement in 2019
• The nuances in compliance areas that create risk and should be closely monitored in your quality system
• The differences and revisions in inspectional programs affecting all medical device regulatory and quality professionals
• Enforcement tools the FDA will be using in 2019 to ensure compliance and evolving trends in how the FDA seeks enforcement
• The business implications of FDA enforcement trends and compliance policy through its new initiatives

1:30 p.m. – 3:00 p.m. EST