Alston & Bird LLP
Cathy Burgess leads the firm’s FDA compliance and enforcement team and co-leads the firm’s FDA practice. Ms. Burgess advises clients on a range of matters affecting prescription and OTC drugs, biologics, medical devices, foods and cosmetics. She has extensive experience regarding current good manufacturing practice (CGMP) regulation and supply chain management. For products regulated under the Federal Food, Drug, and Cosmetic Act (FDCA), Ms. Burgess conducts liability risk assessments and works with clients to identify and analyze potential legal risks associated with their products. She advises clients on quality systems, adequacy of SOPs, investigation reports, inspection management, recalls, and responses to Form FDA 483s and warning letters. Ms. Burgess also 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.
Panel Discussion: The 10 Best — and 10 Worst — Things to Do When FDA Staff Are on Site