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.

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Creating Effective Standard Operating Procedures
Features
Creating Effective Standard Operating Procedures

Personnel management is the most challenging variable in maintaining current Good Manufacturing Practice (cGMP) across the life cycle of drug manufacture, safety, and supply. A standard operating procedure (SOP) outlines agreed-upon instructions for personnel training and instructions for maintaining systems, machines, documents, and records in a qualified state to produce safe products. This...