About Ileana

Internationally recognized regulatory compliance expert with over 25 years of experience at the U.S. Food and Drug Administration, most recently serving as Drug National Expert (Subject Matter Expert) within the Office of Regulatory Affairs (ORA) before her retirement in 2023. Throughout her career, Ms. Barreto-Pettit conducted hundreds of inspections worldwide, where she effectively identified significant Good Manufacturing Practices (GMP) deficiencies that resulted in numerous regulatory actions.

With extensive knowledge and understanding of FDA regulations and expectations, Ms. Barreto-Pettit served as a Senior Trainer in the FDA Drug School for 17 years. In this role, she trained hundreds of new drug investigators and compliance officers on 21 CFR 210 and 211 drug regulations and the inspectional process of sterile and non-sterile pharmaceutical manufacturers.

Ms. Barreto-Pettit is a respected Speaker who has represented the FDA and other pharmaceutical organizations in various agency, national, and international pharmaceutical conferences for the past 25 years to share her insights on regulatory compliance. She brings a wealth of knowledge in pharmaceutical regulatory compliance, combining extensive hands-on inspection experience with a deep understanding of GMP regulations and evolving FDA expectations. Her expertise spans across various aspects of drug manufacturing, from pre-approval audits to post-market surveillance, making her an invaluable asset in navigating complex quality and compliance challenges in the pharmaceutical industry.