Ms. Ahearn specializes in pharmaceutical and medical device regulatory compliance. She has served in numerous roles within the Food and Drug Administration (FDA) including bench chemist, domestic and international investigator, technical liaison for FDA’s Office of Criminal Investigations, and as a member of FDA’s National Training Cadre making her an expert in the interpretation and application of cGMP regulations in 21 CFR 210/211 relating to pharmaceutical manufacturing, and 21 CFR 820 relating to medical devices. Ms. Ahearn has assisted pharmaceutical and medical device companies preparing for FDA inspections, as well as responding to FDA 483 observations after an inspection. She has worked to resolve technical and FDA compliance issues for virtually all pharmaceutical dosage forms and medical device classes.
Ms. Ahearn has worked with manufacturers with such aspects as sterility, material supply chain, vendor auditing, validation programs, laboratory and manufacturing investigations, laboratory and manufacturing audits, and CAPA implementation.