Syllabus
GxP Data Integrity Professional Certificate
33 lessons, about 10 hours. Online and self-paced, with a certificate when you finish.
GxP Foundations and Regulatory Scope
Establish the regulatory, scientific, and operational foundations of trustworthy GxP records, including applicable FDA requirements, international reference frameworks, data lifecycle management, and organizational accountability.
- 1GxP Data Integrity and Regulatory Scope
- 2Regulatory Requirements Across Clinical and Nonclinical Studies
- 3GxP Data Flows and Record Preservation
ALCOA+ and Good Documentation
Translate ALCOA+ principles into practical documentation, correction, transcription, reconciliation, and independent review procedures for paper, electronic, and hybrid regulated records.
- 4ALCOA+ Principles in Daily Practice
- 5Paper Documentation and Controlled Corrections
- 6Delayed Entries and Documentation Exceptions
- 7Hybrid Records and Verified True Copies
- 8Independent Record Review and Approval
Laboratory and Clinical Data Integrity
Recognize common data integrity vulnerabilities in pharmaceutical QC, microbiology, clinical research, bioanalytical testing, and nonclinical studies through realistic regulatory and operational scenarios.
- 9QC Laboratory Data Integrity Red Flags
- 10OOS Results and Laboratory Investigations
- 11Clinical and Bioanalytical Record Integrity
- 12Nonclinical Studies and Clinical Oversight
- 13Cross-Functional Evidence Reconstruction
Electronic Records and Part 11 Controls
Develop practical competency in evaluating electronic record applicability, Part 11 safeguards, electronic signatures, audit trails, system access, validation, and computerized system lifecycle controls.
- 14Part 11 Applicability Assessments
- 15Part 11 Electronic Record Requirements
- 16Electronic Signatures and Identity Controls
- 17Audit Trail Design and Review Fundamentals
- 18Risk-Based Audit Trail Review Exercises
- 19Clinical Electronic Audit Trail Review
- 20Access Management and System Validation
- 21System Suppliers, EU GMP, and Emerging AI Risks
Data Governance and Internal Auditing
Build an effective cross-functional data governance framework, apply risk-based data flow assessments, and conduct internal audits that test the reliability of real regulated records and systems.
- 22GxP Data Governance Program Design
- 23Data Integrity Risk Assessment and Mapping
- 24Risk-Based Data Integrity Audit Planning
- 25Audit Execution and Regulatory Inspection Readiness
- 26Audit Findings and Third-Party Oversight
Investigations and Sustainable Remediation
Apply a structured, evidence-based investigation framework to suspected data integrity events, determine affected data and regulatory consequences, implement effective CAPA, and demonstrate sustained compliance through practical case studies.
- 27Data Integrity Incident Response and Containment
- 28Root Cause Analysis and Retrospective Review
- 29Investigation Scope and Regulatory Impact
- 30Corrective and Preventive Action Planning
- 31CAPA Effectiveness and Sustained Compliance
- 32Integrated GxP Investigation and Remediation
- 33Clinical Data Integrity Remediation Case