James Henderson
Eli Lilly And Company
Computer System Auditor, Global Quality Audit and Compliance
I am currently a Computer System Auditor in the Global Quality Audit and Compliance Group.
Previously, I was the Business/Computer System QA representative for Eli Lilly and Company’s Global Quality Laboratories. I have over 30 years 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. I have been deeply involved in data integrity improvement efforts for the past 10 years. I co-authored and delivered a global project to train QC Lab personnel in data process mapping, identifying and remediating data integrity risks. I co-authored the internal global standard on Laboratory Analytical Equipment Qualification and Software Validation.
External to Lilly, I was a Co-Leads for ISPE Good Practice Guide: Data Integrity by Design. I am currently the Rx-360 Data Integrity Working Group Chair. In this role, I co-authored the new Rx-360 GMP Audit Manual Data Governance and Data Integrity and Selection and GMP Auditing of Software and Hardware Vendors.
Previously, I was the Business/Computer System QA representative for Eli Lilly and Company’s Global Quality Laboratories. I have over 30 years 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. I have been deeply involved in data integrity improvement efforts for the past 10 years. I co-authored and delivered a global project to train QC Lab personnel in data process mapping, identifying and remediating data integrity risks. I co-authored the internal global standard on Laboratory Analytical Equipment Qualification and Software Validation.
External to Lilly, I was a Co-Leads for ISPE Good Practice Guide: Data Integrity by Design. I am currently the Rx-360 Data Integrity Working Group Chair. In this role, I co-authored the new Rx-360 GMP Audit Manual Data Governance and Data Integrity and Selection and GMP Auditing of Software and Hardware Vendors.