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Ms. Jennifer Ahearn specializes in pharmaceutical and medical device regulatory compliance. She has served numerous roles within the FDA including bench chemist, domestic and international investigator, technical liaison for the FDA’s Office of Criminal Investigations, and member of the 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.
ESi's expertise spans dozens of industries and specializations organized across several practice groups, each staffed by dozens of in-house experts with the technical knowledge, hands-on expertise, and courtroom experience required to execute projects for and with our clients from start to finish.Contact Us