Chris M. Hanff, CMQ/OE
, Senior Consultant and Project Lead, CONCORDIA ValSource, LLC
Chris Hanff has over 16 years’ experience in biopharmaceutical operations, quality systems, and has worked on a number of projects ranging from suite start-up and design-construction / commercialization efforts to pharmaceutical manufacturing management. He has extensive experience in essential quality management systems oversight, design, and remediation, including under FDA sanctioned consent decree.
Chris consults for the pharmaceutical industry related to quality risk management, quality systems development and deployment, lean manufacturing, value stream mapping, metrics development, statistical analyses, compliance, TrackWise, DocCompliance and similar enterprise software solutions, aseptic processing, and manufacture. He has a wide range of product experience including biotechnology, sterile product, injectables, lyophilization, medical device, and active pharmaceutical ingredients (API).
Chris has significant depth and breadth of experience as an architect of Quality Systems including: Management Review; Quality Risk Management (QRM); CAPA; Investigations; Complaints; Annual Product Review; Metrics & Trending; TrackWise EQMS; FDA mandated Consent Decree Remediation; Cost of Quality.