James P. Stumpff, RPh

James P. Stumpff, RPh

James P. Stumpff, RPh

Principal Consultant

James draws on 23 years of FDA experience to improve clients’ regulatory compliance. James assists biopharmaceutical and medical device clients with a variety of projects. Examples include: compliance projects including those directed by regulatory actions; expert in Medical Devices, Biologics and Pharmaceuticals including vaccines, biosimilars and combination products; mock FDA audits identifying gaps and developing and implementing comprehensive corrective and preventive actions; regulatory inspection management and FDA Form483 and Warning Letter responses; coaching and mentoring of subject matter experts; and training including GxP, data integrity and inspection management.

Work Experience

Prior to joining Parexel, James served as Investigator, Supervisor and Acting Director of Compliance with the FDA. James managed the pharmaceutical programs for the FDA Los Angeles District for over 10 years. In this capacity he was responsible for pharmaceutical program management including work planning and coordination with the FDA laboratories and the California State Food and Drug Branch. James developed a pharmaceutical GMP training program with the University Of Puerto Rico School Of Pharmacy to assist Latin American companies in compliance; and developed a clinical research compliance workshop with industry to address violations observed during clinical investigator inspections. He was serving as the Acting Director of Compliance for the Los Angeles District upon his retirement from the FDA.

Education

James holds a B.S. in Pharmacy from The University of Missouri-Kansas City and is a member of the Parenteral Drug Association, International Society for Pharmaceutical Engineering and Regulatory Affairs Professional Society.

James has published articles pertaining to drug and device quality system issues in related trade publications and texts. His most recent publication is a chapter in the PDA text entitled “Assuring Data Integrity for Life Sciences” published in 2016. 

We are always available for a conversation.

*