Ileana Barreto-Pettit

Vice President – Technical, Strategic Compliance Consulting
Parexel International
 

During her 24-year tenure at the U.S. Food and Drug Administration, Ms. Barreto-Pettit held various roles, including her most recent position as Drug National Expert within the Office of Regulatory Affairs (ORA). She is considered a subject matter expert (SME) in the FDA’s inspectional process, GMP regulations and expectations, and compliance programs and policies. Throughout her career, she has conducted hundreds of domestic and international inspections of sterile and non-sterile API & finished drug manufacturers where she identified significant GMP deficiencies resulting in compliance actions. These actions have included the immediate cessation of production operations, the issuance of warning letters and import alerts, as well as injunctions, seizures, destructions, and recalls of adulterated drug products.

Ms. Barreto-Pettit has extensive knowledge and understanding of good manufacturing practice (GMP) regulations and expectations and has served as a senior trainer in the FDA Drug School for 17 years. In this role, she has trained hundreds of new drug investigators, compliance officers, chemists, microbiologists, and drug application reviewers on federal drug regulations and the inspectional process.

Furthermore, Ms. Barreto-Pettit has represented the FDA as an SME in various agency, national, and international groups and organizations. She has also played an instrumental role in the revision of international inspectional documents which are utilized by GMP regulators from multiple countries.

 

Sessions: 

Drug – Thoughts from an ex-FDA Drug National Expert on Inspection Readiness & Drug GMP Compliance