James Meckstroth

Mr. James Meckstroth has over 24 years of experience working in the FDA regulated GxP Commercial and Clinical Quality fields. Demonstrated experience with understanding, following, and enforcing various global Health Authority Regulations and Guidelines. He has direct experience in hosting FDA general/pre-approval inspections and internal/external quality audits and administrating independent Data and Safety Monitoring Boards (DSMB). Mr. Meckstroth has broad experience in implementing quality initiatives and restructuring quality systems such as auditing and vendor management, OOS, investigation, risk management, and CAPA. He received a Bachelor of Science in Microbiology from The University of Kansas and a Master of Business Administration from Avila University.