Lisa Olson

Lisa Olson has over 30 years of experience in FDA-regulated industry, with a major pharmaceutical company, three CROs, and in consulting roles.  With a background in system development and support of clinical research systems, she developed her career into regulatory compliance of computer systems and a specialization in 21 CFR Part 11.

Her experience includes clinical data management systems, investigational product labeling and supply, electronic data capture (EDC), IVR systems for drug supply and emergency unblinding, clinical trial management systems, patient diaries, medical imaging, lab, statistical programming, portals, phase 1 unit operations, investigator database, adverse event reporting, and electronic trial master file.

She has assisted companies with identifying applicability of systems to Part 11, performed gap analyses against Part 11, developed SOPs, policies, and position papers, reviewed validation plans and approaches, developed validation document templates, performed internal and vendor audits, facilitated definition of system requirements, helped internal business units with appropriate categorization of risk from issues and CAPA items, provided Part 11 and computer system validation training for a variety of audiences, including IT, management, operational areas, and quality assurance auditors.  She has spoken at numerous industry conferences and professional organization meetings and has participated in industry task groups with FDA representation.

Courses Taught