Kir F. Henrici The Henrici Group

Kir Henrici has extensive industry experience serving as a quality and compliance consultant with special expertise in the area of Data Governance + Data Integrity, IT and Enterprise Data Management, leading global and site level data governance programs to include designing and executing protocol driven DI assessments, risk analysis, remediation plans and process improvements throughout the organization to ensure a holistic integration of DI principles and controls. She has gained global and diverse perspective and working knowledge of quality, compliance and technical challenges and solutions impacting companies around the world; supporting a range of initiatives including global data organizational area quality system audits and assessments; complex risk management and remediation plans; technical reviews of GMP electronic and manual data related to manufacturing and laboratories; and the enterprise harmonization of policies and procedures.

Special achievements include the development and execution of product risk assessments driving the successful release of international drug product batches; the complex remediation for a generic drug company in receipt of a 483 and Untitled Letter which resulted in an NAI outcome for the subsequent FDA inspection; and Pre-Approval Inspection Readiness for a domestic biotech company and a medical device company, both of which yielded product approvals.