While much is changing in Washington, FDA inspections continue, and enforcement remains a priority for the agency. Join us for an informative webinar where we will cover current FDA inspection priorities and recent FDA enforcement developments.
Our webinar includes legal experts from Nixon Peabody and consulting experts from Compliance Architects. Hannah Bornstein is a partner at Nixon Peabody, experienced in advising companies through complex FDA inspections, FDA Form 483s, and warning letters and parallel DOJ actions. Teresa Gorecki, a vice president and lead subject matter expert at Compliance Architects, has decades of executive-level industry experience leading multi-national quality programs. Ricki Chase, who works as an Executive Consultant with Compliance Architects, served at the FDA for many years, including as an investigator in the FDA’s Office of Regulatory Affairs and as a division director, where she led and managed FDA inspection teams and made recommendations on enforcement actions.
During this webinar, our panel of experts will review key steps to take before, during, and after an FDA inspection. We will explore the essential elements of a strong inspection readiness program, what inspectors look for during site visits, and how to effectively prepare for their arrival. From facility readiness to documentation and staff training, this session will provide practical guidance to help your organization navigate FDA inspections with confidence. Our discussion will also address the preparation of effective post-inspection responses.
This webinar is intended for companies subject to the FDA’s inspection authority, including pharmaceutical, medical device, food, and cosmetics companies, as well as entities involved in FDA-regulated clinical trial research.
Speakers
- Hannah Bornstein, Partner, Nixon Peabody LLP
- Teresa Gorecki, Practice Director, Compliance Architects®
- Ricki Chase, Executive Consultant, Compliance Architects®
Continuing Education
This course is eligible for 1.0 General MCLE credit. Click here for continuing education details.