In this program, the speaker will discuss what to expect during an FDA inspection or remote interactive evaluation. The speaker will also discuss how FDA’s foreign and domestic facility inspections are ramping up post-pandemic and whether FDA is moving away from virtual inspections.
Speakers
Cathy L. Burgess, Alston & Bird LLP
Anthony Fanucci, Alston & Bird LLP
CATHY L. BURGESS is a partner at the law firm of Alston & Bird, LLP in Washington, DC, and serves as the co-chair of the firm’s FDA Practice. Her practice focuses primarily on regulatory compliance, product and supply chain risk management, enforcement, and policy matters related to CGMP and QSR regulation of global manufacturers. Burgess provides strategic counseling, conducts internal investigations and special audits related to FDA compliance, and assists clients in designing compliance programs, internal audit programs, and other risk mitigation strategies. She is recognized as a leading practitioner for life sciences, food, and beverage law, and in the area of pharmaceutical and medical products regulation. Burgess previously served as associate general counsel for the American Red Cross, where she was responsible for regulatory matters; providing legal and strategic advice to Red Cross senior management and the board of governors’ Audit Committee on matters related to the Red Cross Amended Consent Decree. She also previously served as the defense team’s first chair for expert testimony on CGMPs and analytical method validation in United States v. Barr Laboratories, widely recognized as the leading case on CGMPs. Burgess earned her JD from The Catholic University of America and a BSFS from Georgetown University.
ANTHONY FANUCCI is an associate in Alston & Bird’s Health Care FDA Group and a member of the Food, Drug & Device/FDA Team. Anthony advises pharmaceutical and medical device companies on complex FDA rules and regulations. His clients value his experience in pharmaceutical analytical chemistry, biopharmaceutics, and pharmaceutical dosage forms and drug delivery systems. Before joining the firm, Anthony served as pharmacist and a pharmaceutical licensing consultant. During his years as a consultant, Anthony co-managed nationwide licensure efforts for six pharmaceutical companies and provided compliance strategies based on company structure, intended market, and products.May 25, 2023
12:00–1:30 PM ET
Registration
This program is limited to FDLI members who are a part of the New to FDA Law & Regulation Group (NFLR), and student members.
APPLY FOR THE GROUP AND REGISTER FOR THE EVENT
New to FDA Law & Regulation Group
NFLR offers young professionals with up to six years of experience an opportunity to connect, learn from their peers, and enhance their skills. Individuals affiliated with member organizations, those employed by the government, and law students are encouraged to participate.
For questions, please contact Bianca Cardona.
