Chris Ganter

Bio:

Chris Ganter, Associate Director of Global Quality Compliance is a career quality assurance professional with 25 years in the pharmaceutical industry.  Chris holds a Bachelor of Science degree in Chemistry from Drexel University and a Master of Science degree in Regulatory Affairs and Quality Assurance from Temple University.  He specializes in Good Clinical Practices (GCP) quality and regulatory inspection management, with special interest in advanced technologies, data integrity, data analytics, and risk-based quality management systems.

Chris began his career in the finished products pharmaceutical Good Manufacturing (GMP) laboratories.  His career path quickly led to a position as auditor of computerized systems validation (CSV) in global quality, auditing vendors and computerized systems in preclinical development (GLP), drug safety (GVP), and clinical operations (GCP).  He eventually found his passion for clinical quality, conducting GCP audits of principal investigator sites, internal processes, and external vendors.  Chris’ interest in emerging technologies has led to experience providing clinical development quality support for software-as-a-medical-device products, real world evidence studies, and artificial intelligence tools.