Auditing Strategies: Enhancing Compliance Through Vendor Management

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.

Mrs. Adahel C. Artze is a results-driven professional with exceptional organizational skills, and quality systems expertise. Mrs. Artze has a strong background in the development and support of quality systems that consistently deliver safe and effective drug tablets, pediatric OTC suspensions, implantable devices and combination products. She has a proven record of results in leadership roles, consisting of regulatory audit and supplier management programs in Pharmaceutical, Clinical, and Medical Device organizations. Adahel earned Bachelor of Science degrees, one in Biology, and another in Chemistry, from Universidad Sagrado Corazon in Puerto Rico, and holds a Master of Business Administration degree from Wilmington University.