Katherine Norris has 15 years of experience in corporate governance and compliance in the pharmaceutical, medical device, over-the-counter consumer products, and cosmetics industries. She has focused primarily on support during investigation and resolution of government investigations and compliance with enforcement actions. Her experience includes the development, execution, and management of compliance programs intended to fulfill the obligations of two corporate integrity agreements, a pretrial diversion agreement, and a non-prosecution agreement.
Ms. Norris has performed substantial internal investigations and supported extensive federal investigations with the U.S. Department of Justice, Health and Human Services Office of Inspector General, Securities and Exchange Commission, Federal Trade Commission, Department of Education, and National Institutes of Health. She has also advised with the remediation of warning letters and 483 observations issued by the Food and Drug Administration. She is a seasoned manager of Open Payments and state physician payment disclosure obligations.
Ms. Norris supports the management of internal and external investigations and attendant outcomes (including CIAs); remediation of compliance concerns relating to promotional, quality systems, post-market surveillance, and clinical trials activities; and operational aspects of compliance program development, management, and oversight, including comprehensive compliance program design, implementation, and evaluation measures. Ms. Norris also advises clients on risk analyses, disclosure programs, auditing and monitoring, promotional copy review, and compliance with Open Payments and international transparency reporting obligations.
The University of Tennessee-Knoxville
Master of Public Administration, summa cum laude
Concentration: Public Policy and Law
University of Alabama, Tuscaloosa
Bachelor or Arts, magna cum laude
Minors: Philosophy; Psychology
NSF Health Sciences
Senior Director, Compliance and Integrity programs
The Spectranetics Corporation
Director, Corporate Compliance
2009 - 2013
King Pharmaceuticals, Inc.
Manager, Corporate Compliance
Baker, Donelson, Bearman, Caldwell & Berkowitz, P.C.
2006 - 2007
News & Insights
- BRGApril 2016
- Pharmaceutical Compliance MonitorMay 11, 2015
Seminars & Speaking Engagements
- May 18, 2016
- December 9, 2015
- October 15, 2015
- September 8, 2015
News & Commentary
- Healthcare Risk Management 37(10)October 2015
- PM360September 16, 2015
- Press releaseNovember 10, 2014
- Society of Corporate Compliance and Ethics
- United States Attorney's Office Healthcare Fraud Working Group (Eastern District of Tennessee)
- BRG Women's Leadership Committee
- United States Army Family Readiness Group
- United States Army Family Care Team