Kir Henrici
Chief Executive Officer – Principal, The Henrici Group

Kir Henrici is a founder and CEO of The Henrici Group; a specialized consultancy focused on by-design digital transformation, data governance, and GXP compliance. Kir is passionate about enabling business excellence, quality intelligence, and compliance by-design through strategic data-driven initiatives rooted in practical, well-integrated operations. She designs and supports the delivery of quality management strategies at the intersection of data governance, CSV and CQV.

Kir is a member of PDA and currently serves on the PDA Regulatory Affairs/Quality Advisory Board (RAQAB).  Kir leads the PDA technical team addressing Data Governance within the QMS and is a co-lead of the PDA Data Integrity and Digitalization Interest group. Kir is currently co-leading the PDA teams submitting comments in response to FDA Guidance, “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision Making for Drug and Biological Products” and “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.”