Mr. Spankie specializes in pharmaceutical and medical device regulatory compliance and has over 19 years of experience in the fields of quality control, chemistry, regulatory compliance, analytical method development, data integrity, and validation.
Mr. Spankie has successfully managed large quality control organizations through warning letter and site remediation projects. In his role as Informatics Specialist, he helped design and implement Chromatography Data Systems (CDS), Scientific Data Management Systems (SDMS), and Laboratory Information Management Systems (LIMS) for both site based and global cGxP networks. He has extensive background in auditing and remediation of data integrity issues and has developed certification programs for data reviewers in regulated environments.
Mr. Spankie focuses on providing compliant, robust, and efficient solutions and processes for validation programs, laboratory and manufacturing investigations, laboratory and manufacturing audits, and data integrity audits and training.