Marie Mathews

Principal
Franklin Mathews Group
 

 

Marie Mathews is the principal of the Franklin Mathews Group, a biopharma quality and regulatory intelligence consulting company.  She is the prior Associate Director of Regulatory Intelligence for Bristol Myers Squibb, where she helped ensure BMS was fully aware and up to date with global health authority policies, regulations and actions.  Marie spent most of her career with the US FDA, where she most recently served as a compliance officer with the FDA CDER Office of Compliance/Office of Manufacturing. She spent nine years as an investigator covering medical device manufacturers, clinical trials, and drug manufacturing and served on the foreign inspection cadre. She received the FDA Individual Commendable Service award for her work as the lead investigator on a sterile medical device prosecution case. She also worked as a field compliance officer specializing in drugs, veterinary drugs and biologics where she handled several injunction cases, some of which included monitoring long term multi-million-dollar remediation plans. She received her B.S. and Master of Science in Pharmacy/Regulatory Affairs from the University of Georgia. She is a highly rated speaker at major GxP conferences on FDA policy, compliance, and mature quality cultures. 

 

Sessions: 

Plenary – Remote Assessments: What Does It Mean? Where’s the Authority?