Alicia Mozzachio

  PhotoAlicia Mozzachio is currently the Acting Division Director in the Office of Policy for Pharmaceutical Quality (OPPQ) within the newly formed OPQ in CDER. Alicia’s division will be working on guidance for industry, regulation changes and compendial/standards organization collaboration. Prior experience includes serving as the Branch Chief for the International Compliance Branch 1 within the Division of International Drug Quality (DIDQ), Office of Manufacturing and Product Quality (OMPQ), Office of Compliance (OC). Alicia’s branch was responsible for evaluating FDA’s international drug inspection reports and determining the actions to be taken against firms failing to comply with CGMP. Alicia has been with the FDA for 20 years in various job roles (investigator and compliance officer) and locations. She began her career as a junior level investigator with FDA shortly after graduating from Temple University School of Pharmacy in Philadelphia, PA. Alicia distinguished herself as a Drug Specialist within her organization before accepting a new position with CDER’s then known Foreign Inspection Team. In addition to her FDA roles and responsibilities, Alicia has deployed with the Public Health Service (PHS) to provide aid to victims impacted by disasters. Alicia has been a member of the FDA Course Advisory Group for FDA’s Basic Drug School since 2009, teaching new investigators the basics of conducting drug inspections. She is recognized as a subject matter expert in the areas of cleaning validation, topical drug products, clinical significance and APIs. She has also given numerous presentations at national and international conferences. Most recently, she represented CDER at various workshops in India speaking on the importance of following CGMP.