Rebecca Olin

Rebecca Olin

Rebecca Olin

Principal Consultant

Rebecca has over 26 years of FDA experience both as a Field Investigator and Reviewer/Inspector for the Center for Biologics (CBER). As a consultant, Rebecca, has helped clients develop responses to Warning Letters and 483s, remediation efforts as a result of Warning Letters and 483s, assessments of Quality Management Systems, pre-FDA inspection audits, review of prospective submissions to CBER, Batch Verification audits and medical device audits.

Work Experience

Rebecca spent 11 years as an FDA Field Investigator focusing on drug, biologics and medical device inspections, and 15 years at the Center for Biologics as a reviewer and inspector.

Education

She was awarded a one-year long term training contract allowing her to study at the Johns Hopkins University Biotechnology Program. She holds a baccalaureate degree in rehabilitation counseling from Boston University and an MSN in Nursing from Yale University.

We are always available for a conversation.

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