Kir Henrici is the CEO of the Henrici group; a boutique consultancy providing strategic quality and compliance solutions to FDA regulated drug, biotech, and medical device innovators around the world. She has a special interest in data integrity and the science of data analytics in the emerging next generation of big data, IoT, smart manufacturing and Artificial Intelligence.
Kir Henrici has extensive industry experience serving in executive and consulting roles for Nutraceutical, Pharmaceutical, Biotech and Medical Device industries, to include managing and supporting FDA inspections, communications and remediation for companies in receipt of 483’s, Warning Letters, Untitled Letters, and Import Alerts. She has gained global and diverse exposure, perspective and working knowledge of quality, compliance and technical projects and solutions impacting companies around the world; supporting a range of initiatives including Pre-Approval readiness, organizational/functional area/quality system audits and assessments, complex risk management and remediation, technical reviews of GMP electronic/manual data related to manufacturing and laboratories, and enterprise harmonization of policies and procedures.
Ms. Henrici has a special focus on Data Integrity, 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 developed and delivered training modules for Data Integrity to meet basic and advanced training requirements that include level one, annual refreshers, and advanced DI training for auditors. Additional core expertise includes Deviation/Investigation Management and Root Cause Analysis, CAPA, Change Control, Risk Management and Validation.
Ms. Henrici has a strong knowledge base of sterile processing/aseptic practices, oral solid manufacturing, continuous manufacturing/Process Analytical Technology (PAT), Quality by Design (QBD), IT and computerized systems and integrations.
Ms. Henrici is also a author/co-author and contributor for presentation(s) and training modules for key industry forums to include PDA/FDA Joint Regulatory Conference, PCCIG, IQPC and PICs. She serves as a Co-Lead for the PDA Task Force team responsible for the Data Integrity in the Quality Management System technical report, and a team member for the DI in Manufacturing technical report. She also serves on the Steering Committee for the PDA Data Integrity Workshop scheduled for fall 2019, and was a contributor to the PDA/DHI Book: Assuring Data Integrity for Life Sciences.