Learning Tracks

FDA Inspectional Oversight

Monday, October 2, 2023

1:30 p.m. - 3:00 p.m.

The COVID-19 public health emergency (PHE) expired on May 11, 2023. And with this, stakeholder questions remain around practices and documents developed and used during Covid. Stakeholders are interested in knowing more about in the area of inspections. For example:

  • Are any further revisions/updates with the Resiliency Roadmap for FDA Inspectional Oversight needed?
  • Is there any information or updates regarding the “unannounced foreign inspection pilot program” that was introduced in the Omnibus Bill?
  • How does the Agency plan to implement its next phase of inspections?
  • We are now well over a year post the PHE. What are some challenges that the Agency is facing as they increase in-person inspections.
  • How has the use of Remote Regulatory Assessments (RRAs) impacted the FDA inspectional process?

These and other questions will be explored to provide attendees with an update and discussion on what to expect related to inspections following the expiration of the COVID-19 public health emergency declaration.

Speakers:

Donald Ashley, J.D.
Executive Vice President, Regulatory Compliance, Greenleaf Health, Inc.

Alonza Cruse, B.S.
Director, Office of Pharmaceutical Quality Operations, Office of Medical Products & Tobacco Operations, CDER, FDA

Sean Kassim, PhD
Director, Office of Study Integrity and Surveillance, OTS, CDER, FDA

Derek Smith, PhD
Deputy Director, Office of Pharmaceutical Manufacturing Assessment, OPQ, CDER, FDA

Joe De Vito, PharmD
Senior Director, Global Quality Compliance, Teva Pharmaceuticals