Cynthia Schnedar

Quality & Compliance Practice

BACKGROUND

FOCUS AREAS

AWARDS & HONORS

30-year career as a compliance expert.
Formerly Director of the Office of Compliance for the FDA’s Center for Drug Evaluation and Research (CDER) where she led efforts to ensure companies complied with federal standards for quality and safety; she also served in leadership roles at US Department of Justice.

Strategic insight for c-suite officials regarding quality and compliance issues
Expertise on compliance issues across the life cycle of medical products
Proactive approach to achieving quality culture throughout the organization.

Food and Drug Law Institute Distinguished Service and Leadership Award
FDA Commissioner’s Special Citation
Attorney General’s Distinguished Service Award
Council of the Inspectors General Award for Excellence.

With more than 30 years of experience as an expert in compliance issues – including more than 20 years in leadership positions in the government – Cynthia adds to ELIQUENT’s prestige in the firm’s Quality and Compliance Practice.

Cynthia was formerly Director of the Office of Compliance for the FDA’s Center for Drug Evaluation and Research (CDER), where she led regulatory enforcement efforts to ensure companies comply with federal standards for quality and safety. Cynthia’s commitment to quality continues in her work advising ELIQUENT clients on GCP and GMP issues across the product lifecycle.

In addition to serving at FDA, Cynthia spent more than two decades at the Department of Justice (DOJ), where she specialized in compliance and enforcement issues. As Deputy Inspector General and Acting Inspector General, she led a nationwide staff in investigating allegations of corruption and misconduct and conducting independent audits of department programs. Through her other roles at DOJ, Cynthia acquired an extensive background in criminal and civil enforcement work, serving as Counselor to the Inspector General, Deputy Chief of the Sex Offense and Domestic Violence Section in the U. S. Attorney’s Office for the District of Columbia, Assistant U.S. Attorney, and Trial Attorney in the Civil Fraud Section of the Civil Division.

Previously, Cynthia clerked for the Honorable James R. Browning on the U.S. Court of Appeals for the Ninth Circuit and worked as a television reporter in New Mexico and Texas.

Cynthia earned a B.A., with distinction, from the University of New Mexico and a J.D., with honors, from the University of Texas School of Law.

Cynthia previously served as a board member for both the Food and Drug Law Institute and the FDANews Editorial Advisory Board. Cynthia served as editor for FDLI’s most current edition of How to Comply with Drug CGMPs, which is a concise reference on the compliance standards and governing principles widely used in industry. She is the recipient of numerous awards, including the Food and Drug Law Institute Distinguished Service and Leadership Award, the FDA Commissioner’s Special Citation, the Attorney General’s Distinguished Service Award, and the Council of the Inspectors General Award for Excellence.