Hear from and meet with key FDA officials and staff who lead all medical device inspectional and compliance activities covering eighteen states from Florida to Minnesota. This interactive FDA session will cover a myriad of compliance and regulatory issues critical to the medtech industry, as well as Q&A and discussion.
Hot Topics: Key FDA priorities & Initiatives
This section will cover program alignment, FDARA, transparency, nonbinding 483 feedback, experiential learning and regulatory convergence/ISO.
Speaker – Blake Bevill, Division Director, Office of Medical Device & Radiological Health Operations, FDA
Med Device Compliance & Enforcement
This section will cover device inspectional issues, top 483 observations and recent trends, cGMP/QSIT compliance issues, Unique Device Identification (UDI), warning letters and device recalls.
Speakers – Melissa Michurski, Director of Compliance (Minn, MN), FDA
Joshua Silvestri, CSO, Investigator/Device Specialist, (Maitland, FL), FDA