Thomas O'Leary

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Compliance Professional
Tom O’Leary is a compliance professional (facilities, utilities, equipment, packaging, and
validation) with over 30 years of experience in EMA and FDA biologics, parenteral, OSD, and sterile
and nonsterile API-regulated industries worldwide. He has conducted cGMP audits; responded
to FDA Form 483s, major findings, warning letters, consent decrees, conducted remediations,
due diligence, and mock audits; and troubleshot systems, processes, and equipment. He has
been an ISPE member since 2014.