Consultant QA, Eli LIlly and Company
Jim Henderson is the Business/Computer System QA for Eli Lilly and Company’s Global Quality Laboratories. He has 30 of experience supporting QC Laboratories in multiple roles: analytical equipment qualification and validation, global consultant for data integrity, and lab analytical equipment qualification and validation. Jim has been deeply involved in data integrity improvement efforts for the past eight years. He co-authored and delivered a global project to train QC Lab personnel in data process mapping, identifying and remediating data integrity risks. He co-authored the internal global standard on Laboratory Analytical Equipment Qualification and Software Validation. External to Lilly, Jim is the Co-Lead for ISPE Good Practice Guide: Data Integrity by Design. He is the Rx-360 Data Integrity Chair. In this role, he co-authored the new Rx-360 GMP Audit Manual Data Governance and Data Integrity and Selection and GMP Auditing of Software and Hardware Vendors.