AI Governance and Model Lifecycle Management (ISO/IEC 42001) for Life Sciences Course & Certification

AI Governance and Model Lifecycle Management (ISO/IEC 42001) for Life Sciences training provides the knowledge and practical skills required to understand, establish, and manage AI governance frameworks using ISO/IEC 42001 while addressing regulatory, ethical, quality, and risk-management expectations across the life sciences industry. It equips learners with a strong foundation in AI Management Systems (AIMS), AI governance principles, leadership and accountability, risk assessment, impact assessment, trustworthy AI, human oversight, lifecycle controls, monitoring, incident management, change control, and continual improvement.
This AI Governance and Model Lifecycle Management (ISO/IEC 42001) for Life Sciences Course & Certification covers the structure and principles of ISO/IEC 42001, AIMS scope and governance, AI policies and objectives, Statement of Applicability (SoA), AI risk and impact assessments, data and model lifecycle management, validation and change control, bias and fairness, transparency and explainability, human oversight, security, robustness and resilience, model performance monitoring, incident and CAPA management, AI system retirement, ALCOA+ documentation principles, internal auditing, certification readiness, and integration with GxP, ISO 13485, ISO 27001, ISO 9001, and the EU AI Act. Learners gain practical understanding of how AI systems can be governed throughout their lifecycle, how emerging risks and performance changes are identified and controlled, and how organizations can maintain responsible, compliant, auditable, and inspection-ready AI systems within pharmaceutical, biotechnology, medical device, clinical research, and other regulated life sciences environments. Upon successful completion, learners receive a certification demonstrating their understanding of ISO/IEC 42001, AI governance principles, AIMS implementation, AI lifecycle management, risk and impact assessment, trustworthy AI controls, and their application within regulated life sciences environments.

• AI Governance and Responsible AI Professionals
• Quality Assurance and Quality Management Professionals
• Regulatory Affairs and Compliance Professionals
• Pharmaceutical, Biotechnology, Medical Device, and Life Sciences Professionals
• GxP, Validation, Computer System Validation, and Quality Professionals
• AI/ML Developers, Data Scientists, and Model Validation Specialists
• Information Security, Privacy, and Data Governance Professionals
• Internal Auditors and ISO Management System Professionals
• Clinical Research, Pharmacovigilance, and Regulatory Technology Professionals
• Professionals seeking a career in AI Governance, AI Risk Management, Responsible AI, and Regulatory Compliance